Taylor v. Canada | Feb 27, 2020

CITATION: Taylor v. Canada (Attorney General), 2020 ONSC 1192

COURT FILE NO.: CV-181819

DATE: 20200227

ONTARIO

SUPERIOR COURT OF JUSTICE

)

BETWEEN:

KATHRYN ANNE TAYLOR

) John Legge, Steve Pengelly, David Steeves,

) and Brian Moher for the Plaintiff

Plaintiff

)

– and –

)

Sean Gaudet, James Soldatich, Andrew Law,

James Gorham, Roger Flaim, for the

Defendant

THE ATTORNEY GENERAL OF

CANADA

Defendant

James Newland, Neil Wilson for the Ontario

Health Insurance Plan

) HEARD: April 1-3, 5, 8-12, 23-26, 29, 30;

) May 1-3, 6-12, 15, 23-26. 29-31; June 3-5,

) 10-13, 17-21; September 16-20, 23; October

) 7-9, 2019

LEDERER J.

INTRODUCTION

[1]

Government regulates many areas of our lives. This regulatory activity is part of what

organizes our society, confirms its values and, in some circumstances, gives direction to what we

can, should or might do. In a culture which values the individual and encourages other

participants (say universities, research entities and corporations) to find solutions to common

concerns, locating the balance between public and private responsibility when things go wrong is

a complicated problem. This case enters into this difficult question but in what turns out to be a

limited way.

[2]

The area being regulated is a form of medical treatment, not the activity of the

professionals involved (doctors and nurses), or the use of drugs but instead so called “devices”

that may improve the circumstances of those in need of relief. This includes, for example, any

apparatus that may be used to augment the structure of the body and improve its function. In this

Page: 2

case, Vitek Inc., a corporation located in Houston, Texas was promoting and selling a proprietary

product (“Proplast”) for a variety of uses associated with an array of physical issues of concern

to many people. Of particular relevance was its use in implants designed to replace the meniscus

in the jaw to alleviate discomfort and improve performance. This occurred at a time of growing

government interest in the entry of these devices into the market and the perceived need for

increased regulation to meet their arrival. Devices using Proplast were implanted into some

Canadian citizens. Today, it is generally accepted that Proplast is frangible (fragile, brittle),

breaks down and that the resulting particles may distribute themselves causing much suffering

and pain such that the use of the jaw may become restricted, in some cases ineffectual. The

Plaintiff says that the defective nature of the product was well-known and understood long

before these implants were put in place. It is said that the fault for the harm that resulted lies, in

part, with the government for its failure to properly regulate and control the entry of Proplast

products into the market and its failure to respond appropriately after the difficulties of the

recipients of these implants became apparent.

HISTORY OF THIS ACTION

[3]

This is a class action. It has a history, not a happy one. The implants which mark the

beginning took place at some point between 1983 and 1990. This action was commenced in

1999. It has taken 20 years to bring it to trial. By my count, from the trial record, with the

delivery of these reasons, no fewer than 23 judicial officers (Masters, Superior Court and Court

of Appeal judges) will have touched this proceeding.

[4]

The initial representative plaintiff was Judith Logan. In 2002 an effort was made to add,

as a plaintiff, Wendy Bulloch-MacIntosh. She had commenced an individual action. The stated

purpose of the motion was to add to the certification record information elicited from

representatives of the Crown during the discovery in that separate proceeding. There was a

threshold issue. Could the individual action be stayed but left in place if Wendy Bulloch-

MacIntosh became a representative plaintiff in the class action? Initially, the judge considering

the matter indicated a willingness to hear further submissions. In the end, the plaintiff withdrew

the request.¹In 2003, Judith Logan was replaced by Kevan Drady and the present representative

plaintiff, Kathryn Anne Taylor.²Kevan Drady withdrew in 2006 to commence a separate class

action alleging negligence over the regulation, by Health and Welfare Canada, of a different

implant, that one using “silastic” (a combination of silicone and plastic), not Proplast. That

action was struck out by the Court of Appeal in 2008 for failing to disclose a reasonable cause of

action.³

¹Trial Record at T. 11 and T. 12 (Endorsements of Mr. Justice Winkler respectively dated February 13, 2002 and

May 15, 2002.)

²Ibid at T. 13 and T. 14 (Respectively the Reasons and Order of Mr. Justice Winkler.)

³Drady v. Canada, 2008 ONCA 659 (CanLII), 300 DLR (4th) 443, 270 OAC 1, 68 CPC (6th) 306, [2008] OJ No

3772 (QL), 169 ACWS (3d) 683

Page: 3

[5]

The first substantive issue that comes to mind is whether, given the time lapse, the action

was commenced outside the applicable limitation periods. At the time, there were two limitations

that could have impacted this case. The first, 6 years as found in the Limitations Act⁴, and the

second the Crown Liability and Proceedings Act⁵which, in turn, adopted whatever provisions

applied in the province where the cause of action arose being, in this case, the Proceedings

6

Against the Crown Act of Ontario. That Act required that at least 60 days before the

commencement of an action against the Crown a notice of the claim be served on the Crown.

The issue of applicable limitations arose as part of a motion heard considering the substitution of

the original representative plaintiff. The question was whether the substitution could not take

place because, in the absence of certification, the putative class action remained an individual

action. This would mean that the “tolling” of the applicable limitation period through the Class

Proceedings Act, 1992⁷had not become effective. The motion judge did not accept this

submission. In any case, as he saw it, there was no need to start a new action. “The most

appropriate approach to deal with the motion to substitute in the present circumstances is by way

of amendment, pursuant to the jurisdiction granted to the court under ss. 12 and 14 of the CPA

[Class Proceedings Act] rather than for the new representative plaintiffs to commence a fresh

proceeding.”⁸Apparently, the issue of whether the action as commenced in the name of Judith

Logan was out of time did not come up. However, it did in the appeal that followed:

In any event the motion judge did not deal with that argument and I can only

assume it was because the argument was not put in that way. In any event,

however it is clear from the disposition made by the motion judge that because the

claim is that the breaches by the appellant are continuing, the action was not, on

its face, barred by the passing of the limitation period.⁹

[6]

of whether this action was out of time has not been raised since. It was not raised at this trial.

The appeal was dismissed. The substitution was allowed.¹⁰So far as I am aware the issue

[7]

The certification of this action as a class proceeding was not finalized until July 6, 2012

following a determination made by a five-judge panel of the Court of Appeal. What did it take to

get to that point? During May, 2000, the plaintiff (still Judith Logan) brought a motion to certify

the action as a class proceeding.¹¹On October 3, 2000, a motion to strike certain materials

included in the Motion Record filed, by the Plaintiff, in support of the motion to certify the

action was heard. Of the six contested items, two were withdrawn, three were struck and for one,

the issue declared moot.¹²

⁴R.S.O. 1990, c. L.15

⁵R.S.C., c. C-50

⁶R.S.O. 1990, c. P. 27

⁷S.O. 1992, c. 6, s. 28

⁸Trial Record at T. 13 (Endorsement of Mr. Justice Winkler at paras. 14-25 (The sentence quoted is at para. 25))

⁹Logan v Canada (Minister of Health) 2004 Canlli 184 (ON CA), 71 OR (3d) 451, 188 OAC 294 at para. 15

¹⁰Ibid and Trial Record at T. 19 (Respectively the Decision and Order of the Court of Appeal both of June 29, 2004)

¹¹Trial Record at T. 7 (Endorsement of Master MacLeod dated July 25, 2001) at para. 12

¹²Ibid at T. 4 and T. 5 (Respectively, the handwritten endorsement and Order of Mr. Justice Winkler dated October

3, 2000.)

Page: 4

[8]

On July 25, 2001, Master MacLeod dealt with a motion, generally, concerning the refusal

to answer questions during a cross-examination conducted in preparation for a motion to amend

the pleadings. What is apparent is that the difficulties that have marked the overall conduct of

this action had already appeared:

A form of procedural gridlock has arisen over this issue notwithstanding

admonitions by the case management judge.¹³

[9]

An appearance was necessary to settle the order. The difficulties that had presented

themselves continued. The Master was required to underscore that the order he had made

required the deponents to the affidavits to reattend to answer the questions asked, as well as

reasonable follow-up questions. As the Master noted, while the issue of a re-attendance is

discretionary, the permission to permit a subsequent examination was, and remains, the “usual

order”. The Master felt the need to go on:

I find it an extraordinary submission that the credibility of these witnesses will

remain an issue on the motion.¹⁴

[10] It seems the Master also had to consider and deal with an allegation of some sort of

improper conduct of counsel for the Plaintiff:

I do not view the affidavits provided by Mr. Legge as an improper attempt to

unilaterally determine the mode of examination but rather as an attempt to provide

timely answers in a cost effective manner.¹⁵

[11] The Master noted the Crown’s response to whatever problem it saw:

Nevertheless, the Crown insists on proceeding orally and there has been no

persuasive argument why this should not be allowed.¹⁶

[12] This all has to do with a refusals motion. One has to wonder why all this obfuscation was

thought to be necessary.

[13] The certification motion was considered in reasons delivered on September 5, 2007. The

action was certified:

The allegations are consistent with an interpretation that Health Canada's failure

to take steps to enforce the regulations and its directions to the distributor of the

devices - despite its knowledge that they were being breached - facilitated the

¹³Ibid at T.7 (Endorsement of Master MacLeod dated July 25, 2001 at para. 12.)

¹⁴Ibid at T.10 (Endorsement of Master MacLeod dated October 9, 2001, p. 2.)

¹⁵Ibid at T. 10, p. 2

¹⁶Ibid at T. 10, p. 2

Page: 5

continued sale of the devices and thereby created a risk to the health of the

intended recipients. Health Canada’s alleged failure to enforce the regulations

when it was aware that sales of the implants were continuing after it had given

notice of breaches on a number of occasions over a period of six or seven years,

could only have encouraged the importer/distributor to believe that it could ignore

its statutory obligations, and Health Canada’s warnings, with complete impunity.

In these circumstances, I believe it would be open to a court to find that Health

Canada’s course of conduct – including the dissemination of the misinformation

in its database - increased the risk to the health of the plaintiff and other potential

recipients of the implants and gave rise to a relationship of proximity with them.¹⁷

[14] The Court pointed out the limits of this determination:

It is possible that the plaintiff will not be able to prove the allegations of fact in

the statement of claim - or that a different complexion may be placed on them

when all the evidence on each side is before the court at trial. These are not

matters I am concerned with on this motion.

[15] But went on to confirm the then pertinent conclusion:

On the basis of the pleading alone, I do not consider it to be plain and obvious that

Ms. Taylor has no chance of success in establishing that a relationship of

proximity – as required to establish a private law duty of care – existed in

connection with operational acts of Health Canada. I believe this conclusion is

consistent with the cases I have cited, and others…¹⁸

[16] A motion was brought to the Divisional Court seeking leave to appeal the order certifying

the class action. Leave was refused.¹⁹

[17] This was not the end of the Court considering the question of certification of the

proceeding as a class action.

[18] A year after the certification motion, the Court of Appeal released its decision in Drady v.

Canada.²⁰It too considered implants to the jaw. In that case, in this Court, the year before, the

same judge, as on the certification motion, had struck the Statement of Claim. Proximity was not

apparent because the plaintiff was unable to identify the particular implant he had received as

being manufactured by Vitek Inc.:

¹⁷Taylor v. Canada (Health), 2007 CanLII 36645 (ON SC), 285 DLR (4th) 296, 49 CPC (6th) 36, [2007] OJ No

3312 (QL), 160 ACWS (3d) 385 at para. 39

¹⁸Ibid at para. 40. (The other citations referred to at the end of the quotation are: Sauer v. Canada (Attorney

General),2007 ONCA 454 (CanLII), [2007] O.J. No. 2443 (C.A.); Swanson Estate v. The Crown (1991), 1991

CanLII 8226 (FCA), 80 D.L.R. (4^th) 741 (F.C.A.); and Williams v. Canada (Minister of Health) (2005), 2005 CanLII

29502 (ON SC), 76 O.R. (3d) 763 (S.C.J.))

¹⁹Taylor v. Canada (Attorney General), 2007 CanLII 55708 (ON SCDC), 289 DLR (4th) 567, 233 OAC 111, —

[2007] OJ No 4947 (QL), 163 ACWS (3d) 368

²⁰Supra (fn. 3)

Page: 6

In these circumstances – independently of any other considerations - the facts

alleged with respect to the Crown's operational negligence with respect to the

Vitek Proplast implants are, in my judgment, insufficient to give rise to

relationship of proximity between it and Mr Drady. Under the FDA and the

regulations, the Crown does not regulate devices generically or by categories. Its

powers and responsibilities are confined to dealing with particular devices sold, or

to be sold, in Canada on a case by case basis. The Crown's alleged negligence in

respect of the defaults of the Vitek Proplast implant vendor cannot create

proximity with Mr Drady if it is not alleged that he received such a device.

Independently of any other consideration, a causal relationship between the

plaintiff, the device and its vendor is an essential link in the creation of a

relationship of proximity. …²¹

[19] The device implanted in Kevan Drady did not use or contain Proplast. It relied on silastic.

The Court of Appeal in Drady considered the Superior Court decisions in both that case and this

one. It confirmed the decision that, in Drady, there was no proximity between the Crown and the

plaintiff. There being no proximity, it was plain and obvious that the action could not succeed.

[20] At about the same time as the decision of the Court of Appeal in Drady v. Canada it also

released its reasons in Attis v. Canada²²which considered the same issues, albeit in relation to

breast implants rather than jaw implants. The legislative scheme did not demonstrate any

intention to impose a private law duty of care²³and there was no direct communication or

interaction between the government and the plaintiff in relation to the operation or

implementation of a policy such that a duty of care could arise. There was no allegation of any

representations by Health and Welfare Canada that were capable of supporting a relationship of

proximity.²⁴

[21] Both Drady and Attis made reference to Sauer v. Canada (Attorney General).²⁵It runs

counter to their determination concerning the absence of proximity. In Sauer, a farmer

commenced a class action as a result of a cow, in Alberta, contracting “BSE” (colloquially “Mad

Cow Disease”). Some countries closed their borders to Canadian beef. The law suit was for

negligent regulation of the cattle industry and claimed for the financial losses suffered as a result.

In certifying the action, the judge considering the motion held that a duty of care had been

disclosed in the pleadings. The Court of Appeal made this observation even though the judge had

not directly addressed the question.²⁶The motion judge had moved directly to the issue of

²¹Drady v. Canada, 2007 CanLII 27970 (ON SC), [2007] CarswellOnt 4631, [2007] OJ No 2812 (QL), 159

ACWS (3d) 177 at paras. 23 and 24

²²2008 ONCA 660 (CanLII), 93 OR (3d) 35, 300 DLR (4th) 415, 254 OAC 91, 59 CPC (6th) 195, [2008] OJ No

3766 (QL) , 169 ACWS (3d) 684

²³Attis v. Canada (Health), supra (fn. 22) at para. 62

²⁴Ibid at para. 66 and 68

²⁵Sauer v. Canada (Attorney General), 2007 ONCA 454 (CanLII), 225 OAC 143, 31 BLR (4th) 20, 49 CCLT (3d)

161, [2007] OJ No 2443 (QL), 159 ACWS (3d) 306

²⁶Taylor v Canada (Health), 2010 ONSC 4799 (CanLII), 81 CCLT (3d) 106, [2010] OJ No 5936 (QL) at para. 30

Page: 7

whether there was a policy rationale for overriding the finding of proximity and the resulting

duty of care as required by the second stage of the test in Anns v. Merton London Borough

Council.²⁷In Sauer v Canada (Attorney General) the Court of Appeal upheld the certification. It

dealt with the issue of proximity in a single paragraph:

On the other hand, Sauer argues that he has pleaded the facts required to show

sufficient proximity between Canada and commercial cattle farmers to raise

a prima facie duty of care. In particular, he points to the many public

representations by Canada that it regulates the content of cattle feed to protect

commercial cattle farmers among others. He says this shows that Canada was

acting with their interests in mind rather than the broad public interest. Sauer says

that Canada’s public assumption of a duty to Canadian cattle farmers to ensure the

safety of cattle feed yields the conclusion that it is not plain and obvious that his

claim of a prima facie duty of care will not succeed. I agree.²⁸

[22] Drady and Attis having been decided and based on what they determined, the Crown

moved, in this action, to strike the Statement of Claim and decertify the class action. The Court

determined that the pleading failed to disclose a reasonable cause of action but granted the

plaintiff leave to amend the Statement of Claim. The Court denied the motion to decertify the

class action.²⁹

[23] In coming to its decision, the Court took account of how each of Drady and Attis dealt

with Sauer:

The treatment of Sauer in these cases is typified by the following comments

in Attis and Drady:

[In Sauer] this court found a sufficient pleading of proximity at

para. 62 on the basis of the many express "public representations

by Canada that it regulated cattle feed to protect commercial cattle

farmers among others" (emphasis added). Accordingly, the

result in Sauer depended on the allegation of specific

representations by the Government that it was acting in the

interests

of

the

plaintiffs.

On

this

basis, Sauer is

distinguishable because the appellants in this case do not plead any

specific representations by Health Canada that it was acting to

protect the particular interests of the consumers of breast implants.

(Attis at para 49)

27

[1977] UKHL 4, [1978] AC 726 (The test established in Anns v. Merton London Borough Council, though later

rejected in England, is still relied on in Canada. It is a broad test for determining the existence of a duty of care. The

test has two stages. It requires first a “sufficient relationship of proximity based upon foreseeability”; and secondly

considerations of reasons (policy) why there should not be a duty of care.)

²⁸Sauer v. Canada (Attorney General), supra (fn. 25) at para. 62

²⁹Taylor v Canada (Health), supra (fn. 26) at paras. 26, 49, 54 and 76

Page: 8

Proximity was also adequately pleaded in Sauer on the basis of the many express

public representations by the government that it was acting for the explicit

purpose of protecting the commercial cattle farmers. These representations

supported the plaintiff’s allegation that the government assumed a private law

duty to act on behalf of the farmers. (Drady at para 42)³⁰

[24] And concluded:

The significance attributed to the representations in Sauer would appear to have

considerable precedential importance for counsel and motions judges when

considering the kind of representations by the Crown that could give rise to a

sufficiently close relationship with the plaintiff.³¹

[25] In the end it was not plain and obvious that the proximity necessary to demonstrate a

private duty of care could not be met:

In these circumstances, I believe I should accept the amended pleading on the

ground that – when it is read generously - it is not plain and obvious that a finding

of proximity could not be made at trial if the factual allegations pleaded are

proven. At the very least, in view of the need for clarification of the requirements

for an effective public assumption of a private law duty of care, I consider

that this is a case in which it should be held that the particular issue on which

proximity turns is not fully settled in the jurisprudence within the meaning of the

decisions cited in paragraph 47 above. In such cases it has been held that the issue

in dispute is best left to be dealt with at trial on the basis of a full evidentiary

record.³²

[26] Instead of proceeding to the Divisional Court and recognizing the confusion the mix of

cases then extant had caused, the Crown determined to move directly to the Court of Appeal. A

motion was brought for leave to have a special case determined. The judge opened his reasons

observing that “[t]his action has had a tortured history”.³³It was 10 years after the action had

been commenced. There had been no progress. The motion was granted, in part out of concern

for the delay:

The parties have indicated to me that this litigation has already become a

procedural marathon. If the case was to follow through the normal course in the

Divisional Court with leave to appeal and appeal in the Divisional Court,

followed by the inevitable application for leave to appeal to this court and the

appeal in this court, then several more months -- if not a couple of years -- will

³⁰Taylor v Canada (Health), supra (fn. 26) at para. 35

³¹Taylor v Canada (Health), supra (fn. 26) at para. 37

³²Taylor v Canada (Health), supra (fn. 26) at para. 73

³³Taylor v. Canada (Attorney General) 2011 ONCA 181, 104 OR (3d) 481, 277 OAC 126, [2011] OJ No 949 (QL).

(A Notice seeking leave to appeal to the Divisional Court, dated September 15, 2010 was filed but no action taken

pending the outcome of the motions seeking a special case (at para. 19).)

Page: 9

have passed. This action was commenced in December 1999 and pleadings have

not yet closed. So much for access to justice!

It is time to get this case moving ahead…³⁴

[27] It is this order that placed the matter before the panel of five judges of the Court of

Appeal. In its decision the Court of Appeal picked up on the general understanding outlined in

Attis to the effect that the proximity necessary to found a duty of care can arise from the

legislation or through direct interaction between the regulator and the individuals impacted:

The approach taken to the claims in Drady and Attis is consistent with that

described above. In both cases, this court looked first at the relevant legislative

scheme and found that it imposed no private law duty of care: see Attis, at

paras. 53-62; Drady, at paras. 37-39. The court then turned to the pleadings in

each case to determine whether the interactions between the regulator and the

plaintiff set forth in the pleadings created a relationship of proximity such as to

justify a finding of a prima facie duty of care.³⁵

[28] The Court rejected the finding, apparent in the determination in Sauer, that the “many

public representations” made by the regulator as to its intention to protect farmers was sufficient

to support a finding of the proximity required as the basis for the existence of a duty of care:

In my view, a finding of proximity based entirely on a regulator's public

acknowledgement of its public duties to those affected by its actions, coupled

with reliance by those affected on the regulator's public statements, is inconsistent

with the Supreme Court's rejection in Imperial Tobacco of the claim that Health

Canada owed a private law duty of care to consumers of low-tar cigarettes

because it had made public representations as to the relative safety of those

cigarettes.³⁶

[29] The Court concluded:

This is not the time or place to pass upon the ultimate sufficiency of the

pleadings in Sauer. I am satisfied, however, that the detailed analyses of

proximity in Attis and Drady, particularly in the light of the subsequent judgment

in Imperial Tobacco, are more in line with the prevailing jurisprudence. The

single conclusory observation in Sauer, standing alone, is not consistent with that

jurisprudence.³⁷

³⁴Ibid at paras. 27-28

³⁵Taylor v. Canada (Attorney General), 2012 ONCA 479 (CanLII), 111 OR (3d) 161, 352 DLR (4th) 690, 293

OAC 312, 95 CCLT (3d) 88 at paras. 92

³⁶Ibid at para 95

³⁷Ibid at para. 97

Page: 10

[30] However, the Court of Appeal was not prepared to foreclose the possibility of the

required proximity being available to the Plaintiff. The inquiry is broader than looking for

immediate and direct interaction between the regulator and the prospective plaintiff:

Where the legislation is not determinative one way or the other, the courts explore

the specific circumstances of the interactions between the regulator and the

plaintiff in the context of the legislative scheme to decide whether a sufficiently

"close and direct" relationship exists to justify the imposition of a prima facie

duty of care…³⁸

[31] The Court addressed the substance of that inquiry:

Findings of proximity based on the interactions between the regulator and the

plaintiff are necessarily fact-specific. The jurisprudence does, however, suggest

there are two important factual features in those cases where the court has found a

prima facie duty of care.³⁹

[32] And explained the two factual features it found important:

First, the facts demonstrate a relationship and connection between the regulator

and the individual that is distinct from and more direct than the relationship

between the regulator and that part of the public affected by the regulator's

work.⁴⁰

And

The second feature of those cases in which the courts have found that the

interactions between the plaintiff and the regulator created a prima facie duty of

care arises out of the nature of the duty actually imposed by the legislative

scheme. While the statutory duties are found to be public duties and not,

therefore, themselves the basis for any private law duty of care, those public

duties have been found to be consistent with the existence of a private law duty of

care owed to an individual plaintiff.⁴¹

[33] On this basis the Court concluded:

³⁸Ibid at para. 79 referring to R. v. Imperial Tobacco Canada Ltd., [2011] 3 S.C.R. 45, [2011] S.C.J. No. 42, 2011

SCC 42 (CanLII), at para. 50; Hill v. Hamilton-Wentworth Regional Police Services Board, [2007] 3 S.C.R.

129, [2007] S.C.J. No. 41, 2007 SCC 41 (CanLII), 285 D.L.R. (4th) 620, at paras. 26-45; Fullowka v. Pinkerton's of

Canada Ltd., [2010] 1 S.C.R. 132, [2010] S.C.J. No. 5, 2010 SCC 5 (CanLII), at paras. 37-55; Heaslip Estate v.

Mansfield Ski Club Inc. (2009), 96 O.R. (3d) 401, [2009] O.J. No. 3185, 2009 ONCA 594 (CanLII), 310 D.L.R.

(4th) 506, 67 C.C.L.T. (3d) 1, 252 O.A.C. 1, 179 A.C.W.S. (3d) 1224 at paras. 15-31.

³⁹Ibid at para. 80

⁴⁰Ibid at para. 80

⁴¹Ibid at para. 88

Page: 11

The jurisprudence permits no definitive answer for the first question. As counsel

for AG Canada put it in his factum, "[t]he requirements for proximity are diverse

and depend on the facts of each particular case".⁴²

[34] The Court of Appeal did not stop there:

…there is no allegation of any direct contact between the plaintiff [Kathryn

Taylor] and Health Canada⁴³

[35] However, the possibility of proximity remained:

…In my view, it is arguable that the misrepresentations, combined with the failure

to correct that misrepresentation in the face of knowledge of the serious and

ongoing risk posed to a clearly definable and relatively small group of consumers,

could be viewed as akin to the regulator's failure in Fullowka to act in the face of

the known and ongoing dangers posed to the small and well-defined group of

miners who worked in the specific mine which the regulator knew to be unsafe.⁴⁴

[36] With this, the action was certified and proceeded as a class action.

[37] Why review this history now? It is unacceptable that it has taken as long as it has for this

action to proceed to trial. The case is premised on the idea that there is a group of people who

have been harmed by the alleged neglect of the government. They have been waiting for twenty

years, their suffering continuing, presumably with the hope, maybe even the expectation, of

some assistance. No one should be content with the time this has taken. Those involved have to

ask why they allowed this to happen. Moreover, what the reasons of the Court of Appeal

demonstrate is that the foundational question to be answered: Did the government owe the

members of the class a private duty of care, is a limited one. No duty of care is imposed by the

legislation. Nor, in this situation, is there proximity as a result of direct and immediate

interaction. What is left is narrow. Is there some identifiable group to which, as a result of some

action by the government, proximity exists and a duty of care attaches?

[38] This is not the only limitation imposed through the history of this unfortunate litigation.

[39] It should go without saying that there are other parties who would have been involved in

the importing, marketing, selling, purchasing, implanting and observing the results of any

surgery associated with the placing of Vitek Proplast devices. These would include the

manufacturer, the distributor, the hospital and various doctors and other professionals. Not

surprisingly, given that the only defendant in this action is the Crown, it issued Third Party

Claims. The Trial Record includes an order, dated September 14, 2006, allowing the Crown, on

consent, to deliver its Amended, Amended, Amended, Amended Third Party Claim.⁴⁵There is

⁴²Ibid at para. 92

⁴³Ibid at para. 107

⁴⁴Ibid at para. 111

⁴⁵Trial Record at T. 23

Page: 12

no earlier form of the Third Party Claim in the Trial Record. Clearly, it had been subject to a

series of changes. There is another order, this one issued on September 25, 2005, as I read it, in

furtherance of the amendment allowed 10 days earlier. It allowed for the discontinuance of the

Third Party action against those that, with the amendments that had been ordered in place, were

no longer the subject of any allegations in the Third Party Claim.⁴⁶

[40] The motion that determined that, in Drady, the Statement of Claim disclosed no

reasonable cause of action was joined by a motion to strike the Third Party Claims in both Drady

and this case. The question that arose concerned what the Plaintiff was claiming and, in

particular, did it leave open the prospect that the Crown, if found liable, could have a claim to

contribution and indemnity as allowed for by the Negligence Act.⁴⁷At the outset, counsel for the

Plaintiff was insistent that the Plaintiff’s claim perceived that the Crown was liable for all of the

damage she had suffered. Counsel for the moving parties (the Third Parties) relied on “a few

references to the Crown’s several liability that appeared in the Plaintiff’s pleadings”.⁴⁸The Court

determined that “several” liability did not foreclose the possibility of contribution from others:

I do not believe there is any doubt that the great majority of situations in which a

right to contribution arises in practice involve several, rather than joint,

tortfeasors.⁴⁹

[41] On this basis, one would expect that the motion was dismissed. It was. But not before

counsel for the Plaintiff had a change of heart. On a subsequent appearance, counsel indicated a

willingness to make clear that while the position remained that the Crown was liable for all the

damage suffered, should it be found that others shared the blame, the Plaintiff was seeking an

award only for the Crown’s proportionate share. This being so there would be no basis for a

claim for contribution. The motion was dismissed but on the understanding that it was open to

the Plaintiff to amend the Statement of Claim to make clear that the liability of the Crown was

limited to its relative degree of fault. An application could then be made for a declaration with

respect to that relative degree of fault.

[42] The order was appealed. By the time the appeal was heard, the Statement of Claim had

been amended to meet the suggestion of the motion judge. Thus, there was no basis for a claim

⁴⁶Ibid at T. 24

⁴⁷R.S.O. c. N.1 Section 1 states:

Where damages have been caused or contributed to by the fault or neglect of two or more

persons, the court shall determine the degree in which each of such persons is at fault or

negligent, and, where two or more persons are found at fault or negligent, they are jointly and

severally liable to the person suffering loss or damage for such fault or negligence, but as

between themselves, in the absence of any contract express or implied, each is liable to make

contribution and indemnify each other in the degree in which they are respectively found to be at

fault or negligent.

⁴⁸Drady v. Canada, supra (fn. 21) at para. 62

⁴⁹Ibid at para. 64

Page: 13

for contribution. The appeal was dismissed. The Court of Appeal took it that the motion judge

had struck the Claim and that he was right to do so.⁵⁰

[43] This is another limitation as to what can be accomplished in this trial. The Court of

Appeal, in dealing with the Third Party claim, observed that the Court maintains the jurisdiction

to apportion fault against a person not a party to the action or, as put by the Court of Appeal:

“…nothing in the language of s. 1 [of the Negligence Act⁵¹] precludes a court from doing so.”⁵²

No one is asking for this kind of apportionment. In this situation it would not be appropriate as a

common issue. The answer would be, or could be, different for every member of the class

depending on who was involved and what role they played. Thus, all that can happen in this

common issues trial is the recognition that there was a duty of care owed and that it was, or was

not, breached. Nothing can be done to assess the degree of fault or the proportion of the liability

attributable to any party. Still it seems not unreasonable to propose, as a possibility, that once

any liability of the manufacturer, distributor, doctors, hospitals and others are accounted for, any

degree of liability attributable to the government might be small, in relative terms and as to its

value.

[44] Another limitation is in respect of the class. How many people are there who could

benefit from a finding in favour of the class? Not many.

[45] How was the class to be defined?

…The classes that the plaintiffs seek to represent consist of persons resident in

Canada, outside British Columbia and Quebec, who received the TMJ implants.⁵³

[46] This is a highly generalized statement. A true understanding of the class requires

refinement. I begin by repeating that the reason Kevan Drady’s individual action failed is

because he was unable to identify Vitek Inc. as the manufacturer of the implant he had received:

In this case, although the allegations relied on by the plaintiff appear to relate to

the same implants (Vitek Proplast implants) of the same vendor/importer whose

breaches of duty were allegedly ignored by the Crown in Baric, it is not pleaded

that Mr. Drady received any such implant.⁵⁴

[47] This class action concerns those who received Vitek Inc. Proplast temporomandibular

joint (jaw) implants. What follows from Drady is that if the individual did not receive one of

these implants, he or she cannot be a member of the class:

⁵⁰Taylor v. Canada (Health), 2009 ONCA 487 (CanLII), 95 OR (3d) 561, 309 DLR (4th) 400, 264 OAC 229,

[2009] OJ No 2490 (QL)

⁵¹R.S.O. 1990 c N.1

⁵²Taylor v. Canada (Health), supra (fn. 50) at para. 27

⁵³Drady v. Canada, supra (fn. 21) at para. 1

⁵⁴Ibid at para. 22

Page: 14

It follows that the scope any duty of care that might exist between the Crown and

those who received the Vitek Proplast implants cannot, in my opinion, extend to a

person who did not receive them.⁵⁵

[48] Understood in this way, membership in the class is narrowly defined: implants made by a

particular manufacturer, utilizing a proprietary product in its manufacture (Proplast), implanted

without the requisite acceptance by the regulator (the granting of a Notice of Compliance), where

the recipient or his caregivers were misled into believing a Notice of Compliance had been

granted when they had not been, or, in circumstances where the Notice of Compliance, though

issued, should not have been.

[49] All of this when the suggestion is that there were few of these implants used in Canada.

There have been doubts about the numbers since the beginning. The following paragraph appears

in the reasons responding to the first certification hearing, the one that took place during June

2007 with the decision being released on September 5, 2007:

Plaintiff's counsel estimated the size of the class to be approximately 2600

individuals. The evidence in support of a number this large is not persuasive. The

estimate is based on information from Health Canada that 26,000 Vitek TMJ

implants were distributed in the United States and an assumption that, based

simply on the relative populations of Canada and the United States, "it would not

be unreasonable" to conclude that 2,600 units were implanted in Canada. The

information from Health Canada on which counsel relied only in part suggests

that the class might not exceed 200 persons.⁵⁶

[50] To the Court of Appeal, at the hearing of the special case, the assumption was that the

group was small:

In my view, it is arguable that the misrepresentations, combined with the failure

to correct that misrepresentation in the face of knowledge of the serious and

ongoing risk posed to a clearly definable and relatively small group of consumers,

could be viewed as akin to the regulator's failure in Fullowka to act in the face of

the known and ongoing dangers posed to the small and well-defined group of

miners who worked in the specific mine which the regulator knew to be unsafe.⁵⁷

[51] This perception is fundamental to the ultimate determination made by that Court. The

finding that it was not plain and obvious that the action could not succeed was based on the

understanding that the interaction that was the foundation of the required proximity was to other

than those affected by the regulator’s regular work, by definition a smaller group. Inspite of all of

this, as late as November 27, 2018, a motion was brought before Master McGraw who, while

acknowledging that some members would have died, understood the size of the class to have

⁵⁵Ibid at para. 25

⁵⁶Taylor v. Canada (Health), supra (fn. 17) at para. 60

⁵⁷Taylor v. Canada (Attorney General), supra (fn. 35) at para. 111

Page: 15

“approximately 2500 -2600 members”.⁵⁸The Submissions of the Plaintiff made at the end of the

trial use the same estimate.⁵⁹

[52] As will become apparent later in these reasons, there is some reason to wonder whether

any of the individuals who testified are, in fact, members of the supposed class. This leaves open

the prospect that there is no class.

[53] There are serious limitations to the impact of any decision the Court may render. There is

only a narrow route to the necessary proximity; it is only the alleged negligence of the Crown

that is at issue, its proportionate share of liability, if any, cannot be determined as a common

issue and the size of the class cannot be determined but could be small.

[54] In this consideration of the history, I move on to production. This was an issue of

controversy throughout the twenty years leading to this trial which continued, despite the efforts

of the Court to bring it to an end, up to and including the last days of the trial. It does not reflect

well on the parties, either of them. To my mind, it contributed substantially to the delay in

bringing this matter to resolution.

[55] On October 17, 2003, Master MacLeod released reasons in a motion dealing with

production.⁶⁰Viewed from the perspective of the time (the beginning of the process) it was both

comprehensive and prescient. It concerned the fundamental obligations of the Crown:

(1) Was it obliged to swear an affidavit of documents in the usual form?

(2) What was the range of documents to be produced?⁶¹

(3) Given the volume of documents to be produced and the production of copies on

CD ROM, what special rules should apply?⁶²

⁵⁸Taylor v. Attorney General of Canada, 2018 ONSC 7235 (CanLII) at para. 7

⁵⁹Submissions of the Plaintiff at para. 3

⁶⁰Logan v. Harper, 2003 CanLII 15592 (ON SC),

⁶¹Ibid at para. 3(b):

i)

type of TMJ implant apparently used in the plaintiff’s jaw?

ii) For the purpose of these cases, what are “documents” and is it necessary to disclose file

Are all documents relating to TMJ implants relevant or only those relating to the specific

folders, file folder tracking information and other documents disclosing who had possession of

or access to particular files at specific times?

iii)

is there only an obligation to disclose relevant documents retrieved from files?

iv) What is the extent of the obligation to provide a complete and comprehensive Schedule

Are files in their original form and order “documents” within the meaning of the rules or

C to the affidavit or list of documents?

⁶²Ibid at para. 3(c) a list was provided, as follows:

i)

Should the defendant be required to share its software for searching the CD ROM

version of the documents?

Page: 16

(4) Should Health Canada disclose how the search for documents was conducted,

who conducted it and what search criteria were used?

[56] In answering the questions that were put to him, the Master made an observation pointing

to the problem the parties faced:

A large document case, requires a specific plan for organized access to the

documents. Tracking document locations and permitting inspection of originals is

particularly problematic if the documents or files are required for the day to day

operations of an organization or if they may be subject to production in more than

one proceeding and may be required in the future. In such situations, the

immediate production obligation must be balanced against the need to maintain

the ongoing viability of the filing system. Production obligations can be onerous

and disruptive to an organization and some balance must be struck.⁶³

[57] He made plain the risk and advised as to the solution:

Finally, to avoid complete chaos on both sides, the organization and production of

the documents for the purpose of the litigation should ideally utilize a jointly

accepted plan of organization, authentication, identification and retrieval. What is

necessary therefore is definition of the scope of production, a production

procedure that is understood and accepted and liberal doses of procedural

collaboration and common sense. In these actions, I invite counsel to agree on the

plan but if agreement cannot be achieved, court management and supervision of

the production and discovery process appears necessary.⁶⁴

[58] The Master understood that, in this situation, there were practical limits to the process:

The plaintiffs wish paper copies of every document and wish to inspect every

original document. As I understand it they also wish to see every document in its

original file folder in original order and they wish production of the file tracking

documents or stamps which are believed to show who within Health Canada had

possession of any file and at what time. In the particular circumstances of this

case with the volume of documentation involved, that demand is unrealistic,

onerous, expensive and excessive. It is unnecessary for every document to be

subjected to this level of scrutiny. There is a right to inspect original documents

ii)

Notwithstanding the production of scanned, indexed and potentially text searchable

versions of the documents, is the plaintiff entitled to insist upon inspection of every original

document?

iii)

Must Health Canada provide paper copies of the documents in addition to the CD ROM

versions?

⁶³Ibid at para. 27

⁶⁴Ibid at para. 27

Page: 17

and there may be relevance to file tracking information or file organization but it

is necessary for such rights to be exercised in a focussed and targeted manner.⁶⁵

[59] All of which speaks to the clear-headed observation that some cooperation and

understanding needed to be applied to the difficulties of this particular document search.

[60] Fifteen years later, on October 29, 2018, a motion was brought before Master McGraw.

The motion was, in part, for an order striking out the Statement of Defence for “…the alleged

failure to produce documents pursuant to court orders, specifically the order of Master MacLeod

(as he then was) dated October 17, 2003”.⁶⁶This was taken in the face of a trial date that had

been set by Mr. Justice Firestone, a year earlier, on October 31, 2017. The Master was aware of

the problematic nature of this request. He wondered if some other remedy, one that would allow

the action to continue to trial, had been considered. He was advised that a proposal had been

made by the Plaintiff and rejected by the Crown. The motion began. Counsel for the Plaintiff, at

the conclusion of his submissions (approximately three hours into the motion) changed his

position. He advised the Court that rather than the striking of the defence, the Plaintiff was

seeking an order requiring further production including examination of a non-party, a former

employee of Health and Welfare Canada. The Crown was unable to respond. It had prepared to

answer what the Master referred to as the Plaintiff’s “aggressive and exclusive pursuit of

dismissal of the Defence”.⁶⁷The Master was confronted with a problem. As he saw it, even if the

Court was to make the order on that day, it was not practical to expect that it could be complied

with by the trial date that had been set, January 14, 2019:

Given the age and volume of the documents sought, some of them over 30 years

old and others which may no longer exist or are in dated electronic format that

must be located and searched, I am not satisfied that all steps contemplated by the

Proposed Order can even be completed in time for trial, let alone in time for any

documents produced or examination transcripts to be used as evidence at trial.

Further, if the Defendant wishes to oppose certain terms of the Proposed Order, it

is entitled to additional time to properly respond to the Plaintiff’s change of

position and the late filed materials. All of this must be balanced with the

Plaintiff’s entitlement to relevant documents prior to trial, particularly in a

procedurally and substantively complex matter such as this.

[61] It seems there was the risk of a further motion seeking a further examination:

Further, there is still the possibility that the Defendant will be bringing a motion

to examine Dr. Blais…⁶⁸

⁶⁵Ibid at para. 28

⁶⁶Taylor v. Attorney General of Canada, 2018 ONSC 6808 (CanLII) at para. 1

⁶⁷Ibid at para. 7

⁶⁸Ibid at para. 8

Page: 18

[62] The Master, relying on rules 37.02(2)(b) and 1.04 adjourned the motion sine die (without

a day), and returned the matter to Mr. Justice Firestone for directions with respect to the fixed

trial date, the motion and the changed relief being sought by the plaintiff.

[63] Justice Firestone issued a procedural order on November 5, 2018. A new trial date was

set, April 1, 2019, peremptory to all. The parties were ordered to attend before Master McGraw,

on November 27, 2018 and November 29, 2018, for the return of the motion. To ensure there

were no further delays, Mr. Justice Firestone added as a term of his order that there were to be no

further motions prior to trial other than those that might be heard by the trial judge.

[64] The motion was brought back before the Master who released his reasons on December

3, 2018. There were no fewer than ten motions (eight by the plaintiff, two by the Crown), all

dealing with production and requests for further examinations.⁶⁹The situation confronting the

Master was complicated by the history and the circumstances:

⁶⁹Ibid at para. 1:

i.)

the Plaintiff’s motion to compel the AGC to locate and produce copies of all versions of the report

prepared on May 28, 1981 by Dr. Pierre Blais, the Plaintiff’s key witness and a former research scientist in

Health Canada’s (“HC”) Medical Devices Bureau from 1976 until 1989, entitled “Plastic Fluid Handling

Systems and Implanted Devices: Rationale for regulatory amendments” (the “1981 Report”) together with

audit trails and search parameters as evidence of such efforts;

ii.)

the Plaintiff’s motion to compel the AGC to locate and produce electronic versions of all

documents for which the AGC disputes authenticity;

iii.)

the Plaintiff’s motion to compel the AGC to locate and produce publication and/or presentation

approval sheets for all papers prepared by Dr. Blais together with the underlying documents submitted in

support of such approval requests;

iv.)

v.)

the Plaintiff’s motion to compel the AGC to produce Dr. Blais’ personnel file;

the AGC’s motion to compel the production of Dr. Blais’ original documents for forensic

examination;

vi.)

the AGC’s motion to compel answers to undertakings and refusals arising from the examination of

Dr. Blais on September 26, 2018;

vii.)

the Plaintiff’s motion for the continued examination for discovery of Dr. William Freedland on

refusals from his discovery and questions properly arising therefrom, or, in the alternative, an order that Dr.

Freedland be examined pursuant to Rule 31.10;

viii.)

the Plaintiff’s motion to take the evidence of Dr. Napke, Dr. Neville, Dr. Blais and Kathryn Taylor

before trial pursuant to Rule 36.01;

ix.)

x.)

the AGC’s motion for the examination of Dr. Blais pursuant to Rule 31.10; and

the AGC’s motion to take the evidence of Francine Jacques and Dr. Noel Rose prior to trial

pursuant to Rule 36.01.

Page: 19

These 10 motions proceed in less than ideal circumstances. This is a 19-year,

procedurally and substantively complex class proceeding where the parties have

been engaged in ongoing production disputes for over 15 years. The documents

produced and sought are voluminous with many of them over 30 years old and

some even over 40. Some documents may no longer exist, previous searches may

not have located them and the potential places to search for documents is

overwhelming. Combined with the fixed peremptory trial date of April 1, 2019,

this strikes at the heart of proportionality and requires a balancing of the parties’

entitlement to know the case they must meet through the production of relevant

documents and right to oral discovery prior to trial and the efforts and costs

imposed on the other party. Quite simply, there is not enough time until trial to

complete the additional, comprehensive procedural steps which the parties seek

and which would be ideal for a case of this nature in the current circumstances.⁷⁰

[65] Master McGraw recognized that there had been delay, that both parties were at fault:

With the volume of available and searchable documents and a trial commencing

in 4 months, it is not possible to reconcile all of the parties’ positions and

allegations with respect to the Production Motions. They have not been resolved

over the last 15-plus years and there is no time to resolve them now. Both parties

must bear responsibility for the delayed, late and inadequate productions over the

last two decades and no purpose would be served in determining who is more to

blame at this time. This includes issues arising from the AGC’s alleged and/or

apparent non-compliance with the 2003 Order and Master Haberman’s directions

and the Plaintiff’s late delivery of documents in the possession of her key witness

19 years into the proceedings and 21 years after his involvement with related

actions. It is also inevitable that the de-certification, appeal and related pleadings

amendments have also contributed to the delays and complexity of these

proceedings. In my view, any allegations regarding the sufficiency, timing and

propriety or production are more appropriately issues for costs, either on these

motions or at trial, together with whatever conclusions or inferences the trial

Judge may draw generally. Allegations of spoliation are more appropriately an

issue for the trial Judge in any event (Muskoka Fuels v. Hassan Steel Fabricators

Ltd., [2009] O.J. No. 4782 (S.C.J.) at paras. 5-7).⁷¹

[66] Master McGraw considered each of the ten motions. The decisions he made ordered

some targeted searches and some specific searches; some to be done electronically, with the

provision of a description in each case of the Crown’s best efforts including where it searched,

the search terms; and at least one physical search (material associated with Pierre Blais). Orders

were made requiring two witnesses (Pierre Blais and Francine Jacques (Gaudette)) to be

examined, one in Toronto and the other in Montreal, and for the Plaintiff to submit

interrogatories to be answered by various of the Crown’s employees (Dr. Freedland, Dr. David

⁷⁰Taylor v. Attorney General of Canada, supra (fn. 58) at para. 5

⁷¹Ibid at para. 21

Page: 20

Taylor and Lindsay Blaney). Time limits were imposed: 45 days for some of the items ordered,

by February 28, 2019 for others and 60 days for the interrogatories.

[67] What is clear is the intention of both Mr. Justice Firestone and Master McGraw that this

would be the end of what had been an ongoing dispute concerning production. It was not. On

March 19 and 20, 2019, less than two weeks before the trial was to begin, the Crown produced a

book of fresh documents. Counsel for Plaintiff submitted he had been asking for some of them

over an extended period of time. Not surprisingly, the Plaintiff complained. This required an

appearance on March 22, 2019. Counsel for the Plaintiff cited the long history of attempts to get

complete production from the Crown. Counsel asked for an adjournment. Counsel for the Crown

acknowledged that some of the documents should have been produced earlier but also suggested

that the Plaintiff was already aware of some of those that were the subject of this late production.

The adjournment was refused. A series of directions were provided to overcome the difficulties

the situation presented. Among them, that of the documents that were the subject of the motion,

the only ones that could be produced at trial were those the Plaintiff agreed to or those the

Plaintiff indicated an intention to rely on.

[68] There was a further and subsequent complaint. During March 2018 the Plaintiff produced

some documents from Dr. Pierre Blais. He had had the documents for at least 30 years. The

Crown had indicated an intention to question the authenticity of certain of those documents. This

was among the ten motions heard by Master McGraw and considered by him in his reasons of

December 3, 2018. Expert reports were referred to. The Plaintiff did not have them. This

spawned another request for an adjournment by the Plaintiff. The adjournment was refused but

the issue delayed to be dealt with after all the other evidence was completed, if the Crown

remained intent on raising the issue.

[69] As late as September 13, 2019, the Friday before the trial was to resume following a ten

week break, with only one defence witness remaining to be called, counsel for the Plaintiff wrote

to the Court seeking a motion for directions for, among other things, production and

examinations surrounding the issue of the authenticity of the impugned documents of Pierre

Blais. Counsel for the Crown responded by letter, the same day, sparking a response, in turn,

from counsel for the Plaintiff which included the following paragraph:

Mr. Gaudet’s letter revives the Plaintiff’s concerns about the AGC’s continuing

non-compliance with prior production Orders. This noncompliance vitiates the

Plaintiff’s ability to advance her case. Relevant documents were and continue to

be withheld from production and discovery. Trial fairness cannot be restored

without focussed remedial relief and sanction.

[70] I have reviewed the letter from Mr. Gaudet. I am hard pressed to understand how it would

be a catalyst for going back to Master MacLeod’s order of October 17, 2003. It does not matter.

What this exchange demonstrates is that to the very end, 16 years after the order of Master

MacLeod, the parties continued to battle over productions. Like Master McGraw I see no

purpose in trying to assess blame. I say only that it is clear that the injunction of Master

MacLeod, that cooperation was required, was not adhered to. This was to the detriment of the

parties and to the proceeding.

Page: 21

THE COMMON ISSUES

[71] Out of the history of this proceeding and its certification was the identification of the

common issues to be dealt with in this trial. They are:

(1) Did Canada owe a duty of care to class members?

(2) If so, did Canada breach the applicable standard of care?

(3) If so, can Vitek Proplast temporomandibular joint implants cause injury to those

receiving them?

THE REGULATORY REGIME

[72] The Food and Drugs Act was passed in 1920. Statutory provisions specifically dealing

with medical devices were first enacted on May 14, 1953 and came into force on August 16,

1954.⁷²The Food and Drugs Act was introduced at the material time, as it is now, as “An Act

respecting food, drugs cosmetics and therapeutic devices”.⁷³What is a “medical device”? The

Food and Drugs Act did defined the term “device”:

“device” means any article, instrument, apparatus or contrivance, including any

component, part or accessory thereof, manufactured, sold or represented for use in

(a) the diagnosis, treatment, migration or prevention of a disease,

disorder or abnormal physical state, or the symptoms thereof, in

man or animal,

(b) restoring, correcting or modifying a body function or the body

structure of a man or animal,

(c) the diagnosis of pregnancy in humans or animals, or

(d) the care of humans or animals during pregnancy and at and

after birth of the offspring, including care of the offspring,

and includes a contraceptive device but does not include a drug.⁷⁴

[Emphasis added]

[73] For the purposes of these reasons, we are concerned with subparagraph (b).

Temporomandibular joint implants replace the meniscus that separates two elements of the jaw,

the fossa and the condyle, to allow for its proper movement.⁷⁵

⁷²Agreed Statement of Facts at para. 13

⁷³R.S.C. 1985 c. F. 279 (The definition has since been amended)

⁷⁴R.S.C. 1985 c. F. 27 at s. 2

Page: 22

[74] Beginning in December 1954 and through August 1975 “devices” were also subject to

the provisions of the Food and Drug Regulations. The concern for and interest in the regulation

of medical devices galvanized in and around 1975. This was occasioned by two unfortunate

examples: the Dalkon Shield, an intrauterine contraceptive device, and the nuclear batteries

utilized in pacemakers inserted into the heart. The former caused infection; the latter

disintegrated in the body. A third factor was the “beginning of intraocular surgery”.⁷⁶As a result,

on September 2, 1975, the Medical Devices Regulations, a regulation specific to these devices,

was introduced.⁷⁷Among other things, the Medical Devices Regulations govern the entry of

devices into the market in Canada. From the outset, the Medical Devices Regulations prohibited

the importation into Canada of any device the sale of which would violate any part of the Food

and Drugs Act or the Medical Devices Regulations.⁷⁸On March 25, 1977, a limited form of pre-

market review was introduced into the Medical Devices Regulations.⁷⁹It was restricted to “new

devices”. “New devices” were, and remain in the current version of the regulations, defined as:

“new device”, in relation to a manufacturer, means a device listed in the table to

this Part that

(a) has not been sold previously in Canada by that manufacturer,

(b) it is, in respect of any characteristic, different from any device

sold previously in Canada by that manufacturer, or

(c) is, in respect of all characteristics, identical with a device sold

previously in Canada by that manufacturer that has previously

been recalled or withdrawn from the market or that he has ceased

to manufacture or sell.⁸⁰

[Emphasis added]

[75] As of the promulgation of the Medical Devices Regulations on March 25, 1977, the

“device[s] listed in the table to this Part” included only: (1) Intra-uterine devices and (2) Cardiac

⁷⁵The Agreed Statement of Facts at para. 42 describes the temporomandibular joint as follows:

The TMJ is comprised of the condylar head of the mandible, the glenoid fossa of the temporal

bone and an interposed articular disc. Additionally, these structures are supported by a joint

capsule and ligaments and are connected to the muscles of mastication.

⁷⁶Transcript of Pierre Blais (April 26, 2019) at pp. 49-51

⁷⁷Consolidated Regulations of Canada (1978) Volume VIII, Ch 871

⁷⁸SOR/75-526 at s. 15 and Consolidated Regulations of Canada (1978) Volume VIII, Ch 871 at s. 16:

Subject to section 19 [subsequently s. 20], no person shall import into Canada for sale a device

the sale of which in Canada constitute a violation of the Act or these Regulations.

⁷⁹Agreed Statement of Facts at para 18 referring to Medical Devices Regulations, amendment SOR/77-258,

Schedule II, s.28

⁸⁰SOR/77-258 at s. 28 (in the current consolidated regulation s. 32)

Page: 23

pacemakers. A manufacturer of a “new device” was prohibited from selling or advertising that

device unless the manufacturer received a Notice of Compliance from Health and Welfare

Canada. To obtain a Notice of Compliance, the manufacturer was required to submit to Health

and Welfare Canada evidence establishing the safety and efficacy of the new device. On October

8, 1982, the Table to Part V of the Medical Devices Regulations was amended to extend the pre-

market review to any “new device” designed to be implanted into the tissues or body cavities of

a person for 30 days or more.⁸¹This amendment became effective on April 1, 1983. From this, it

is apparent, and it was not disputed, that what in 1977 was Part IV of the Medical Devices

Regulations and is now Part V applied to the Vitek Proplast Implants that are at the centre of this

proceeding. To be clear it was understood and accepted by all parties that in order to be

mandated for sale in Canada these products required Notices of Compliance. It should be said

that a Notice of Compliance allows the product involved to be sold and used in Canada.

However, it signifies only that the submissions made in support of the application “complied”

with the legislative requirements. A Notice of Compliance is not a statement by the government

that the product is safe, only that the work required to justify its entry into the Canadian market

according to the tests set out in the Medical Devices Regulations has been completed. In short, a

Notice of Compliance is not a guarantee, by the government, that the device is safe for use and

will assist in reducing pain or benefit the problem being treated. The review it conducts is as to

the sufficiency of the work; it is not a peer review as to how it was conducted or a replication

that confirms the results. The legislation makes clear that the responsibility to conduct proper

studies lies with the manufacturer.

[76] At the time the submissions seeking Notices of Compliance for the products of interest to

this case were made there was some suggestion, by those applying, that the product had been

“sold previously in Canada” and that they should be “grandfathered” and not treated as “new

devices”. Documents that purported to confirm those sales were not accepted as such by the

representatives of Health and Welfare Canada. As the Plaintiff has asserted, and as the Defendant

has readily conceded, they had to be treated as they were, that is, as new devices to which the

requirements of Part V of the Medical Devices Regulations applied.

⁸¹Agreed Statement of Facts at para. 21 and Consolidated Regulations of Canada (1978) Volume VIII, Ch 871 and

Medical Devices Regulations, amendment SOR/82-914:

SCHEDULE

The table to Part V of the Medical Devices Regulations is revoked and the following substituted

therefore:

…

3. Any device designated to be implanted into the tissues or body cavities of a person for 30 days

or more.

Page: 24

[77] There were criteria applicable to the content and assessment of the submissions made to

support the request for any Notices of Compliance for “new devices”. Under the heading:

“Submission” the Regulation noted:

s. 35(1) For the purpose of obtaining a notice of compliance, the manufacturer of

a new device shall submit to the Director

(a)

evidence of the safety of the device consisting of at least

(i)

the name and mark under which the devices to be sold,

the purpose of the device and its method of use,

the performance characteristics of the device,

(ii)

(iii)

(iv)

the specifications and limits set for those materials of the

device that may come in contact with body tissues or fluids and a

summary of the test methods used to ensure conformity with those

specifications and limits,

(v)

if sold as sterile, the method of sterilization and the

recommended method of resterilization, if applicable,

(vi)

a general description of the plant, equipment and

procedures used in the manufacture of the device,

(vii) the quality control program and procedures used ensuring

manufacturing, packaging and sterilization of the device, and

(viii) that full data of all chemical studies, analysis and animal

studies carried out to determine the bio-compatibility of those

materials of the device that may, in the normal use, come in

contact with body tissues or fluids;

(b)

evidence of the effectiveness of the device, consisting of at least

(i)

the results of all clinical trials to show the effectiveness of

the device,

(ii)

where clinical trials have not been made, the results of

animal studies or appropriate tests that demonstrate a probability of

effectiveness in humans, and

(iii) all known adverse reactions or contra-indications to the use

of the device under the recommended conditions; and

Page: 25

(c)

drafts of all labels, package inserts, product brochures and file

cards to be used in connection with the device.

(2) Where the Director is of the opinion that the evidence and materials submitted

by a manufacturer pursuant to subsection (1) are not sufficient for him to

determine whether or not he should issue a notice of compliance for the purpose

of selling or advertising the new device, the Director may require the

manufacturer to submit to him further information concerning the device or any

samples of any of the ingredients or components of the device and of the device

itself.

[78] Under the heading: “Issue of Notice of Compliance”:

s. 36. Within sixty days after the latest date of the receipt by the Director of

evidence, materials or information submitted by a manufacturer under section 35,

(a)

where that Director is satisfied that the manufacturer has provided

substantial evidence that

(i)

the conditions of production and quality control are suitable for

controlling the quality, stability, safety and performance of the new

device,

(ii)

the new device can be used for the purpose and under the

conditions of use recommended by the manufacturer without undue risk to

humans,

(iii) the new device is clinically effective for the purpose and under the

conditions of use recommended by the manufacturer or that sufficient animal

studies have been carried out to establish a probability of effectiveness in humans,

and

(iv)

the drafts of all labels, package inserts, product brochures and file

cards to be used in connection with the device are adequate,

the Director shall issue to the manufacturer a notice of compliance; or

(b)

where that Director is not satisfied that the manufacturer has provided the

evidence referred to in paragraph (a), the Director shall refuse to issue a notice of

compliance and shall notify the manufacturer of his refusal and of the reasons

therefore.⁸²

⁸²SOR/77-258 s.31 and s. 32 (in the current consolidated regulation s. 35 and s. 36)

Page: 26

[79] Accordingly, the regulation, in the form applicable when the requests for Notices of

Compliance were made, first in 1987 and again in 1988, continued to require a demonstration of

both “safety” and “efficacy”. As was acknowledged by at least two witnesses called by the

Plaintiff⁸³, these two requirements do not stand as independent standards to be treated and

considered separate and apart, one from the other. They are not absolute tests measurable on a bi-

lateral basis: either safe or not safe; either effective or not effective. Instead they function as two

ends of a spectrum: at one end devices which are safe but do nothing to alleviate the illness or

disfunction which requires treatment, and at the other end, devices which may cure the concern

but at the price of some other undeniable harm. Obviously, neither of these two extremes would

generate the issuance of a Notice of Compliance. The determination of whether to issue a Notice

of Compliance is a consideration of where, on the continuum between these two extremes, taking

into account the degree and likelihood of relief measured against the risk of further harm, the

predicted functioning of the device may fall and whether on that basis it is appropriate to issue a

Notice of Compliance:

Q. And we hear the terms evidence of safety and efficacy throughout the last

month. Can you give us your overview of what that means?

A. Safety and efficacy are the two essential attributes that are demanded of a

medical device, offered up matter of drug as well. It is a quantity that is measured

against the importance of the need that it fulfills. For example, a product can be

highly efficacious and very safe, but totally useless medically. Conversely a

product can be extremely dangerous and would have a strong possibility of being

an inefficacious but is essential surgically. The balance between the two is the

area that we are now discussing.⁸⁴

[80] What this demonstrates is that there is no, and can be no, certain or definitive answer. It is

a balancing and, thus, inherently contains a high degree of discretion and consideration specific

to the individual case.

[81] The limitation imposed by the regulation sets the context in which the choice is to be

made. There is a time limit. The decision is to be taken within 60 days. This is not much time to

consider the kind of detailed studies new approaches to science and treatment, by their nature,

require. Hence the proposition that the determination to be made is not as to the rectitude of the

studies but as to whether they comply with the regulations that govern these submissions.

[82] The evidence shown by the studies was required to be “substantial”: first in showing

“safety” measured as use “without…undue risk” and second, either clinical efficacy (efficacy

demonstrated through trials on humans) that shows the device to be effective under the

conditions of use recommended by the manufacturer or efficacy shown through animal studies

that establish a probability of effectiveness in humans.

⁸³Transcript of Pierre Blais (April 26, 2019) at pp. 71-73 and Transcript of Richard Lawuyi (May 27, 2019) at

pp.43-46

⁸⁴Ibid (Pierre Blais) at p. 71

Page: 27

[83] The answer as to whether a Notice of Compliance should be issued is to be arrived at

within the time frame set and consistent with the standards to be met. Finding the balance

between “safety” and “efficacy” reflects on the two competing policy values at the core of the

regulatory scheme. On the one hand, our desire to have those in the industry find, develop and

produce devices that will assist those who are suffering and on the other to avoid causing more

harm. Later in these reasons I will be referring to “Cotrel rods” which were, and may still be,

implanted in some, particularly teenagers, to assist in remedying curvature of the spine. Surgeons

complained because these devices could not be sold and used because the necessary Notices of

Compliance had not yet been issued. They wanted to help their patients. They had to wait for the

issuance of a Notice of Compliance that was first refused pending the delivery of more

information and later granted. On the other hand, it is generally known (I believe I can take

judicial notice) that Dalkon Shields which were made available for sale were not sufficiently

tested and caused considerable damage. The policy formulation is directed to avoiding both these

results but inevitably will not always succeed. Heather Sheardown is a Professor in the

Department of Chemical Engineering at McMaster University. I will say more about her

qualifications later in these reasons. For the moment I only point out an example she provided

where despite the best intentions, the balance failed. A cornea transplant was approved by the

Federal Drug Administration in the United States in 2001. It was received by thousands of

patients. By 2007 the failure rate of 50% became widely known. Some patients went blind.

Heather Sheardown noted that in many cases we simply do not know what the long-term impacts

of these new medical devices will be.⁸⁵Nirmala Chopra, who was for a time, in charge of the

premarket review of medical devices, advised the court that there was an expectation that some

new devices would cause some difficulty and that generally they would be identified within the

first five years of any new device entering the market.

PROPLAST

[84] Proplast is a trademark that is used to describe a family of composite materials that were

designed, manufactured and sold by Vitek Inc., a Houston-based company founded by Dr.

Charles Homsy in 1969.⁸⁶Proplast is composed of a fluorocarbon polymer matrix and a

reinforcing material, such as fibre or powder. The fluorocarbon polymer matrix includes

Polytetrafluoroethylene (“PTFE” commonly referred to as Teflon) and may include Fluorinated

Ethylene Propylene (“FEP”) polymers and/or fluorocarbon polymer fibres. The reinforcing fibres

or powder may be an organic or inorganic material, including carbon fibre, aluminum oxide or

hydroxyapatite. The added fibres or powder are intended to provide enhanced mechanical

strength while the fluoropolymer is intended to provide a chemically inert, continuous host

material, or polymer matrix.⁸⁷

[85] Proplast has been produced in at least three standard types: Proplast I (PTFE/carbon

competent material), Proplast II (PTFE/aluminum oxide competent material) and Proplast HA

⁸⁵Transcript of Heather Sheardown (May 30, 2019) at pp. 45-46

⁸⁶Agreed Statement of Facts at para. 43

⁸⁷Agreed Statement of Facts at para. 44 referring to Exhibit 8: Expert Report of Dr. Christopher K. Ober, August

24, 2018

Page: 28

(PTFE/hydroxyapatite competent material).⁸⁸Proplast has been manufactured in a variety of

forms including films, sheets, blocks and coatings. In each case, Proplast may be different –

different composition, different manufacturing processes and different physical and chemical

properties.⁸⁹All types of Proplast have in common soft PTFE fluorocarbon polymer resin and

fibre that dominate their surface properties and form a porous matrix. The Proplast types are

distinguished by differences in the filler that lead to differences in mechanical and other physical

properties between the Proplast types.⁹⁰

[86] The Plaintiff does not agree that the various Proplast products are different. Relying on

the evidence of Elliot Wayne Tunis, a physician who had implanted Vitek Proplast

temporomandibular implants, the Submissions of the Plaintiff (the written submissions presented

on her behalf at the conclusion of the trial) note:

There was no difference between the Proplast IPIs and Proplast sheeting with

Teflon laminated to it, other than that the IPIs were manufactured from these

sheets by cutting the sheet into an anatomic size.⁹¹

[87] What is important is that for the purpose of regulating the devices in issue, those

responsible for premarket review of the many Proplast products saw differences. As we shall see,

the complaint made at the time the first applications for Notices of Compliance were received

was that they had been lumped together such that it was not possible to attribute the supporting

data to the specific devices to which it applied. The applications were refused. When a second

attempt was made, the same concern arose. Eventually the regulator (not the applicant) organized

the devices into eight groups, presumably to assist Vitek Inc. Even so, as will become apparent,

the various Vitek Proplast products were treated differently. Some were issued Notices of

Compliance (Proplast Block and Sheeting); many were not (Proplast IPI’s).

[88] Proplast was used as a material component of temporomandibular joint implants

produced by Vitek Inc. and available to Instrumentarium Inc. to be distributed in Canada.

Proplast was intended to anchor the implant to the upper bone of the temporomandibular joint.

it’s porous nature and potential for tissue ingrowth were intended as a feature that would

encourage stability in the temporomandibular joint.⁹²Over time it became apparent that the

PTFE (Teflon) included as part of certain forms of Proplast could, after being implanted,

fragment, delaminate or otherwise be damaged. Debris in the joint from implants could

contribute to progressive bone degenerative change and giant cell reaction.⁹³In time there was a

product recall.

⁸⁸Exhibit 51 at T. 1 (Expert Report of Dr. Doran Ryan, July 28, 2018) at p. 21

⁸⁹Exhibit 8 (Expert Report of Dr. Christopher K. Ober, August 24, 2018) at p 5

⁹⁰Ibid at p. 6-7

⁹¹Submissions of the Plaintiff at para. 20 in turn footnoting Tunis Transcript page 66. (The evidence of Elliot

Wayne Tunis was in the form of a Cross-examination conducted in another proceeding. The basis for its acceptance

as evidence in this trial is reviewed at para. [178] herein.)

⁹²Agreed Statement of Facts at para. 48

⁹³Ibid at para. 114

Page: 29

WHAT WAS KNOWN ABOUT PROPLAST, BY WHOM AND WHEN WAS IT KNOWN

[89] Science does not tend to develop understanding in moments of immediate and complete

insight. Rather it evolves over time. Robert Pilliar testified at the trial. He is an engineer by

training but has worked, taught and studied in the area of medical devices for many years. When

he first appeared, he seemed to acknowledge this perspective but when called in Reply he

demurred. As he perceives it, evolution is a process generally applicable in biology. As he sees

it, science does not evolve so much as it moves through steps.⁹⁴For the purposes of these reasons

such a distinction does not matter. The point is that our understanding of science changes and

becomes more complete as our knowledge and experience increase. Nonetheless, movement “in

steps” suggests a linear progression (both forward and backward). Evolution in its current

understanding is a broader concept. Among its definitions:

A process of change in a certain direction…a process of continuous change from

a lower, simpler or worse to a higher, more complex or better state…a process of

gradual and relatively peaceful social, political and economic advance…a theory

that the various types of animals and plants have their origin in pre-existing types

and that the distinguishable differences are due to modifications in successive

generations… a process in which the whole universe is a progression of

interrelated phenomena⁹⁵

[90] Each of these meanings connotes continuous and gradual change that can occur in a

variety of circumstances. In this case, in the overall appreciation of the risks and harm associated

with Proplast, one of the issues raised was whether this potential should have been appreciated

sooner by Health and Welfare Canada such that entry into the market of any Proplast related

product, at least for use as temporomandibular joint implants, should never have taken place,

should have been recalled sooner and patients directly advised of the risks. To analyse this

proposition (and using what has become a too often used colloquialism) it is important to come

to an understanding of who knew what and when they knew it.

[91] The evidence addressing the question of the degree and timing of any understanding

concerning the usefulness of Proplast products began with Pierre Blais. He was a research

scientist employed by the Medical Devices Bureau (and its successors) from its inception until

his departure in 1989. In the context of this trial, he was a controversial figure. From the

perspective offered by the Plaintiff, Pierre Blais was central to the understanding, within Health

and Welfare Canada, of Proplast and its dangers. Attention was drawn to meetings and

conferences he said he attended, papers he wrote, a book he contributed to and warnings he said

he instilled in more senior officials at Health and Welfare Canada. With a closer look, the idea of

this pivotal role dissipates in the uncertainty and confusion that accompanied his participation in

the events he referred to and in the trial. He left his employment with Health and Welfare Canada

under difficult circumstances. He was terminated for an alleged failure to comply with internal

⁹⁴Transcript of Robert Pilliar (September 23, 2019) at p. 24-25

Page: 30

policy governing, among other things, release of information to the media.⁹⁶He grieved. The

grievance was settled. He was reinstated but retired a day later.⁹⁷He was called as a witness, not

by the Crown, but on behalf of the Plaintiff. He had been available to the Plaintiff’s counsel for

many years. Even so, in 2017, he produced documents that had not previously been seen.⁹⁸He

happened on them when going over files he maintained in his home. The authenticity of four of

these documents was questioned by the Crown. At a pretrial conference during the weeks leading

up to the commencement of the trial, counsel for the Plaintiff advised they were unprepared to

deal with the issue. One of the reports on which the Crown sought to rely had not been delivered.

The Plaintiff required time to retain an expert, prepare a response. This resulted in one of the

adjournment requests to which I have already referred. This was refused. The issue was set aside.

The documents in issue were to be admitted without reference to their authenticity. That issue, if

the Crown still intended to proceed with it, would be heard in a separate proceeding at the end of

the evidence but before final submissions were made. Although not without difficulty, as the end

of the evidence approached, that is what happened.

[92] I will refer to each of the four documents as they become relevant. This is provided at the

outset of these reasons in response to a proposition put in the “Submissions of the Plaintiff”. It is

said there that the allegations made against Pierre Blais should be rejected. This is not surprising

but it is not all that was submitted. Counsel for the Plaintiff goes on:

But in the aftermath of those findings, the Plaintiff submits that Dr. Blais’

evidence must be accepted as true. Indeed the AGC resiled from its decision to

call Health Canada witnesses who would have been in positions to refute Dr.

Blais’ evidence.⁹⁹

[93] In other words, as counsel sees it, if the four documents are found to be authentic, there

need be no further inquiry into the reliability of what those documents say, or it would seem, the

value of any of the other evidence provided by Pierre Blais. To my mind, this is wrong in a

profound way. If the documents are authentic, their reliability, probative value and impact in

contrast to what others have said would remain open for the Court to examine. I go further. It

would be a failure of the Court, in carrying out its responsibilities, if it did not do so. If the

Crown had other relevant evidence that it could have called and chose not to do so, that is a risk

it took.

[94] For all of his experience, the Plaintiff did not seek to qualify Pierre Blais as an expert. In

the Submissions of the Plaintiff, Pierre Blais is referred to as a “non-party, lay witness”. He is

not a party but I am uncertain as to the implication of his being a “lay witness”. It is undeniable

that he was employed through the material time, by Health and Welfare Canada, at the Medical

Devices Bureau, through whatever name changes and restructuring that occurred during that

⁹⁶Exhibit 34 at T. 11 (Letter dated July 14, 1989 Dr. A. J. Liston to Pierre Blais.)

⁹⁷Ibid at T. 12 (Settlement Offer)

⁹⁸Transcript of Pierre Blais (May 10, 2019) at p. 425-428 and 442-443

⁹⁹Submissions of the Plaintiff at para. 152

Page: 31

period. The meaningful distinction, at least as I understand it, is as a “fact” as opposed to an

“expert” witness. I take this to be the import of the Submissions of the Plaintiff where the

following is said:

The Plaintiff called Dr. Blais as a lay witness because of his first-hand knowledge

that Health Canada’s middle and senior management knew that Proplast was

unsafe from the early 1980’s onward.¹⁰⁰

[95] I mention this because much of the evidence of Pierre Blais dealt with the state of

knowledge concerning Proplast as time progressed. What may be interpreted as fact today may

not have been understood as such at an earlier time. As will become apparent as these reasons

proceed, what the Plaintiff, relying on Pierre Blais, believes should have been understood early

in the progress of these events is not so certain. This is especially so when the evidence of Pierre

Blais is fully examined and considered in the context of what was said by others. At the time,

perhaps still, there are experts who do not agree with what the Plaintiff takes to be fact. Some of

this is better understood, at least at the times in question, as opinions. Nonetheless, so far as I can

recall (there were 55 days of evidence) not once was the evidence given by Pierre Blais objected

to as crossing from fact to opinion. I take his evidence to be demonstrative of what he saw as fact

but which others may have seen differently. I believe this to be consistent with the evidence and

how it was provided but also sensitive to the understanding that broad scientific acceptance is not

generally a matter of immediate insight but the result of the sort of evolution that occurs over

time as experience increases knowledge.

[96] As explained by Pierre Blais, the Medical Devices Bureau was formed in 1975. It was a

consolidation of those parts of the Health Protection Branch that were concerned with non-drug

health care products. Pierre Blais recalled that he was the fifth employee brought into the new

Bureau.¹⁰¹The catalyst for this consolidation was the appearance of non-drug medical devices

(such as the Dalkon Shield, pacemaker batteries and the beginning of intraocular surgery), and

the need for the responsibility for their regulation to have a home. As depicted by Pierre Blais

this reorganization was not a well-planned response to the developing concerns. “It was

opportunistic in a sense. It was done piecemeal. And there was no precedent…”¹⁰²

[97] In summer of 1976, Pierre Blais attended a Gordon Conference.¹⁰³While the origins,

source and substance of “a Gordon Conference” was not reviewed, it seems that this was one of a

series of such conferences covering wide areas of scientific interest. Dr. Charles Homsy, the

person recognized as the developer of Proplast, made a presentation. It concerned Proplast and

its properties. Those in attendance were identified by Pierre Blais as “one half of the

¹⁰⁰Ibid at para. 148

¹⁰¹Transcript of Pierre Blais (April 26, 2019) at p. 47)

¹⁰²Ibid at p. 51

¹⁰³At first Pierre Blais recalled this conference as taking place during 1977. However, the program of the conference

says it was 1976 (Exhibit 34 v. 1 T. 15) as do the notes prepared, at the time, by Pierre Blais (Exhibit 34 v. 1 T. 16).

(p. 15) see also Transcript of Pierre Blais (May 10, 2019) at p. 483

Page: 32

contributors to the biomaterials of tissue and bone in the world”¹⁰⁴[Emphasis added]. He stated

his own immediate response:

I was very disappointed by the lecture, but other attendees had other views.¹⁰⁵

[98] He went on to describe the general reaction of those in attendance. It was more than

disappointment. It was outrage. As witnessed by Pierre Blais the scene was one of

“pandemonium.” Charles Homsy was besieged by questions from an audience angered by what

he was saying. As outlined by Pierre Blais, the expressed concerns included:

…why Doctor Homsy was promoting the use of a product where the components

were individual carcinogens or collective carcinogens, firstly. The second

concern was that they were complaining that the mere totality of his formula were

so irritating that they would produce an outright rejection reaction on simply

being there. A third concern was that the photographs and the photo micrographs

that Doctor Homsy had shown before showed the Proplast to be disintegrating and

they had not discussed this.

…

It was the overlying, the fact that the material did not have enough strength to

remain together and that the debris was being disseminated throughout the tissue

and the living organism through fluids, such as the lymphatic fluid were the key

concern to the whole thing and was the basis for why the audience was very

unfavorably inclined.¹⁰⁶

[99] This evidence was anecdotal. There is no data, analysis, report or reviewable assessment

of any potential risk on which a regulator could rely in examining the overall value of the

product. There are some handwritten notes made at the time by Pierre Blais. They include

negative comments with respect to another of the presenters (“PURE BULL” repeated 13 times)

but only technical observations insofar as what was said by Charles Homsy.¹⁰⁷Even so, those at

Health and Welfare Canada took account of what Pierre Blais described. Upon his return he

reviewed what had taken place with his immediate superior, Dr. Ronald Campbell and the

director of the Medical Devices Bureau, Dr. Ajit DasGupta. As Pierre Blais recalled, they met

with the personnel of the Bureau responsible for those devices treated by Part V of the Medical

Devices Regulations (“new devices”) as well as those responsible for the notification

requirements applicable to other medical devices.¹⁰⁸The investigation went beyond the Bureau

¹⁰⁴Transcript of Pierre Blais (April 26, 2019) at p. 123

¹⁰⁵Ibid at p. 122-123

¹⁰⁶Transcript of Pierre Blais (April 26, 2019) at p. 124-125

¹⁰⁷Exhibit 27 v. 3 at T’s A, B, C and D

¹⁰⁸To my mind there is some confusion in this, given that the amendments to the Medical Devices Regulations

which introduced the concept of “new devices” did not become effective until March 25, 1977. At the time it was

introduced, it was Part IV. In any case, the point is that at the time those responsible followed up on the information

brought back by Pierre Blais from the Gordon Conference of 1976.

Page: 33

through telephone calls with, and visits to, parties known to be reliable. A conclusion was

reached. The product was not being sold in Canada through any recognized means or distributor.

[100] In the period following the Gordon Conference, Pierre Blais says he continued to raise

concerns:

Q. Between 1977 and your ultimate final leaving of Health and Welfare Canada

at the end of 1989, were you engaged in any debate with any co-worker at Health

and Welfare Canada of any rank about the safety of Proplast?

A. Yes.

Q. With whom?

A. The mere totality of the early generation of evaluators and then later in formal

lectures that I would give to other members of the department who were not part

of the Bureau, specifically, the field operations group. I recollect, and I may even

have notes about a lecture that I delivered on frangible implants in connection

with the Montreal group, and in connection also with the Toronto field operations

group.¹⁰⁹

[Emphasis added]

[101] Pierre Blais told the Court that by 1981 there was a common view extant in Health and

Welfare Canada that the product was “damaging”:

Q. I’m asking if there was any debate within Health and Welfare Canada that

there was a safe use or an efficacious use for Proplast?

A. Such debates did take place, but only in the academic sense. There was

unanimity in the belief that the product was very much damaging from certainly

1981 onward, and that was general. It was not just one, one view, or even the

official view of our directorship, it spread to everybody...¹¹⁰

[Emphasis added]

[102] To suggest that there was no one at Health and Welfare Canada who wondered whether

the product had value is not accurate. Dr. John Orpin, Medical Advisor, Division of Clinical

Assessment, Bureau of Medical Devices¹¹¹voiced a caution that patients not be deprived of

something useful.¹¹²As put by Pierre Blais this was explained as follows:

¹⁰⁹Transcript of Pierre Blais (April 29, 2019) at pp. 11-12

¹¹⁰Ibid at p. 14

¹¹¹Exhibit 27 v. 3 at T. H (Letter January 17, 1985 (Dr. J.A. Orpin to Dr. M.T. Cooper)

¹¹²Transcript of Pierre Blais (April 29, 2019) at p. 108

Page: 34

John Orpin, who was also a colleague and a co-worker under Dr. Campbell, and

his comment was that – how did he put it – he said but what if perchance it has

some value. By declaring it unsuitable and unacceptable, could we be depriving a

patient of something that could be useful. But it was not a criticism. It was not

someone who supported Proplast. Quite on the contrary. He was simply

advocated that could we possibly have made mistake. It was the only exception.¹¹³

[103] The source of any information that contributed to this “unanimous belief” was Pierre

Blais. No additional work or research was referred to. There is no suggestion that over these

years any notification or application for a Notice of Compliance, along with the data that would

be required with such a submission, was received for any Proplast product, much less for use as a

temporomandibular joint implant. There is no suggestion that prior to 1981 there were any sales

or use of Proplast temporomandibular joint implants in Canada.¹¹⁴

[104] The evidence, taken as a whole, suggests that Pierre Blais did not play the role he has

defined for himself. Some of the employees at the Health Protection Branch had never met him,

others say he played no role they are aware of in respect of Proplast and others say his primary

interest was with the difficulties being encountered with breast implants. There were people who

disagreed with him. They were referred to by Pierre Blais as dissenters:¹¹⁵

¹¹³Ibid at p. 107

¹¹⁴At Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. 2 T. 84 and Exhibit 73 T. 4 at p. 14 there is reference to two

Proplast-like knee implants:

A Canadian Dow Corning representatives [sic]in Montréal recently disclaimed having ever sold

Proplast products. Reports of unregistered 'clearinghouse' distributors, mail order advertisements

and commercial irregularities involving Proplast and Vitek have been received. Two cases

involving implantation of Proplast-like material to the knee were uncovered in the Québec city

area incidentally to a study on knee surgery….

With respect to temporomandibular implants the same document notes, at the same page:

Adverse events surround the use of Vitek Proplast in the US and a controversy has broken out in

Louisiana dental surgery circles. The Canadian Dental Association was informed about the

matter. Complications emerge first in situations involving the temporo mandibular joint (TMJ)

repair. An investigational Vitek implant claimed to be suitable for insertion during a simple

office procedures is [sic] presently promoted for mild discomfort and noise incidental to

movement of the jaw. Such a procedure is evidently gaining popularity in the US but may not

have reached Canada yet. Major problems are expected if and when and if it does.

The document from which these quotations are extracted is one of the four the authenticity of which is been

questioned by the Defendant. For the purposes for which these quotations are used here, I point out only that these

were implants inserted into the knee and not as temporomandibular joint implants. The two knee implants are

discussed in a handwritten memo dated September 9, 1982 from P. Blais to Dr. M. T. Cooper (Exhibit 27 v. 1 T. 12

at p. 000069)

¹¹⁵Transcript of Pierre Blais (April 29, 2019) at p. 14 (Dissenter recorded in the transcript as “descenders” which I

take to be a typographical error.)

Page: 35

However, there were [dissenters] who were not within the community, who were

not within Health and Welfare who occasionally advocated that there were

potential useful applications for Proplast, but they were not National Health and

Welfare people.

[105] Who were they? The quotation immediately above is followed by:

They were individuals representing manufacturers associations. They were

individuals who might have presented in connection with a clinical trial, for

example, the hernia patch issue. There were people who may have been a third

party or agents acting on behalf of Vitek or Novamed, but these were not people

from National Health and Welfare. You could deem them to be promoters or

stakeholders, I think is the word we used, for the product.¹¹⁶

[106] In other words, they were the people interested in having the product come to market.

The same people who would have conducted any tests necessary to show that it could be used

safely and to the advantage of patients who were suffering.

[107] Can the attitude of Pierre Blais, demonstrated by the broad statements he made, be

explained or at least a context for understanding be identified? The controversy that surrounded

his departure from Health and Welfare Canada was not the first time he had run afoul of its

senior representatives. In April 1981, Pierre Blais was interviewed by a journalist working for

the Ottawa Citizen in respect of the use of DEHP [“di(2-ethylhexyl) phthalate¹¹⁷] in blood

transfusion products. He was quoted as saying that “those who give blood through

plasmapheresis… Could face a long-term risk of kidney or liver injury” and that “the use of

plastic containing DEHP is a senseless and unnecessary risk”¹¹⁸. Pierre Blais’ comments

generated considerable consternation among senior officials at Health and Welfare Canada. In a

memo dated May 4, 1981, addressed to the Director of the Medical Devices Bureau, the Director

General of the Environmental Health Directorate, Dr. Emanuel Somers, expressed his concerns

over Dr. Blais’ conduct:

Let me say that I regard Dr. Blais' performance to be alarmist, misleading, and, in

the final analysis, irresponsible. To elaborate, Dr. Blais is employed as a research

chemist to study and advise on the physical and chemical properties of

biomaterials and polymers. He has not the expertise or capability to advise on the

toxicology of chemical materials. That responsibility rests with the Bureau of

Chemical Hazards, whose staff comprise a number of experienced toxicologists

with the required knowledge and ability… Once again, Dr. Blais is pontificating

beyond his responsibility or expertise.¹¹⁹

¹¹⁶Ibid at p. 14

¹¹⁷Agency for Toxic Substances and Disease Registry, Division of Toxicology, Public Health Statement (September

2002): “A manufactured chemical that is commonly added to plastics to make them flexible.”

¹¹⁸Transcript of Pierre Blais (May 13, 2019) at p. 528

¹¹⁹Ibid at p. 52-528 and Exhibit 34, Tabs 11, 12 and 66

Page: 36

[108] There is a memo dated May 4, 1977. It is shown as being from “P. Blais, Materiaux De

Las Medecine” to “B.N. Thivierge, Chef Division Des Affaires Reglementaires”.¹²⁰It is one of

the four documents the authenticity of which was questioned by the Crown. The document along

with the other three where the issue was raised was subjected to forensic analysis by experts

employed by the Canada Border Service Agency in the Analytical and Forensic Services

Division, Science and Engineering Directorate. I begin by observing that regardless of whether

the document was “authentic”, which in the context of this case means that it was written on the

date shown on its face as opposed to sometime later, it would be of little probative value. The

document asked about the existence of files related to several stated subjects (“Sacs A Sang, Sac

Pour Parenteraux, I.V., Specimens, Notification”) and asked specifically whether the recipient

had a recollection of a file named “Silicone Injectable, Polytef and Proplaste”. The reference to

Proplast in a memorandum asking whether there is a file that includes in its name the word

Proplast does not help in understanding what was known or not known about material associated

with that word.

[109] The work done by the experts does not support a finding that the document was not

prepared on the date shown, for the purpose stated. The document is not typed. It is

“handprinted”. It has a handwritten signature above the printed name “P. Blais” and, in the upper

righthand corner, above the printed letterhead, “MEMORANDUM NOTE DE SERVICE”, it

has, in handwriting, words identified in evidence as “plastics site”. For the purpose of “Hand

printing Comparisons” the document is included in the first of two groups of documents being

examined. The conclusion respecting its authenticity, insofar as the hand printing is concerned,

was stated as:

Conclusion: this finding provides more support for the belief that the questioned

hand printing entries in Group 1 were written during the latter period of the

specimen hand printing from 1989 or later, rather than on the dates they are

purported to be produced. However, this support, while greater for the belief that

the writing is anachronistic than it being contemporary, is limited or weak.

This comparison was hampered, and the conclusion severely limited, by 1) the

small amount of specimen writing for the time period after 1989, and 2) the subtle

and variable nature of the features upon which the assessment is based which

creates significant uncertainty in the final conclusion.¹²¹

[Emphasis added]

[110] This document is dominated by the hand printing. Even so the experts go on to examine

the signature found above the hand printed “P. Blais”. Under the heading “Signature

Comparisons” this signature is dealt with in the second of two groups. The conclusion is as

follows:

¹²⁰Exhibit 27 T. 2 and Exhibit 73 T. 3

¹²¹Exhibit 74A (Forensic Laboratory Report 27 February 2019) at p. 37 of 84

Page: 37

Conclusion: This finding provides support for the belief that the questioned

signatures on Items Q1 [the document presently being considered]…were written

during the latter time period of the specimen signatures (2000 and after), rather

than in the time period of the earlier specimen signatures (1966-1991). The level

of support is considered to be strong.

The comparison and the conclusion were limited somewhat by the relatively small

amount of specimen material provided for the timeframe after 1991.¹²²

[Emphasis added]

[111] To place the noted concern (being the small number of specimens available for the period

after 1991) in context, the number of specimens relied on for the identified period are: two from

1991, one from 2000, one from 2005 and three from 2018. To put it differently, “After 1991” but

before 2018 there are only two specimens. The three from 2018 are all signatures by which

Pierre Blais swore to the accuracy of three affidavits that bear his name. The expert

acknowledged that this is an unusual circumstance. It is one which may lead a party to be more

attentive of the act of signing.

[112] The question being asked is a serious one. It is about the fundamental integrity of the

individual involved. I am not prepared to find, on a balance of probabilities, that this document is

anything other than what it appears to be.

[113] I feel obliged to make a further observation. This is not the only one of the four

documents being questioned which has little if any probative value in respect of the issues raised

in this case. None of them do. From this, one has to wonder why the Crown felt compelled to

continue with the issue of their authenticity. I asked about the purpose. The first time the

question was asked, counsel indicated concern for what this might say about the integrity of

Pierre Blais. When the issue arose again the Court was advised that there is a separate

application brought by the Plaintiff by which her counsel seeks to demonstrate that the Crown

destroyed documents presumably knowing them to be relevant to this case. Counsel for the

Crown expressed the view that any decision made in these reasons respecting this issue could

impact that further application. To the extent that the rationale for the inquiry into the

authenticity of these documents is the impact these reasons may have on a further application, it

is collateral to the matters of concern in this trial. If it is the only true purpose, it is improper. The

issue of the destruction of documents is not before the Court. To my mind, any findings made

here should not be taken as determinative of issues to be raised after what would be a more

complete evidentiary investigation specifically directed to those questions.

[114] There was some confusion as to what exactly Pierre Blais did upon his return from the

Gordon Conference. In an affidavit he swore on January 16, 2000 he deposed that “after my

¹²²Ibid at p. 38 of 84

Page: 38

return to Canada I wrote a proposal recommending the prohibition against materials like

Proplast/Vitek.” In this affidavit Pierre Blais goes on to say that he took his recommendation that

Proplast be prohibited to his superior, Dr. Ron W. Campbell, that “to the best of [his]

information knowledge and belief” Dr. Ron W. Campbell passed the recommendation on to the

Director of the Medical Devices Bureau, Dr. Ajit K. DasGupta, that on the same basis he

understands that Dr. Ajit K. DasGupta agreed with the recommendation and passed it on to Dr.

Emmanuel Somers, who according to the information, knowledge and belief of Pierre Blais

rejected the proposal. There is no document that would support this recollection. The Rules of

Civil Procedure, at the time this affidavit was sworn, as they do now, required that when a fact is

attested to on “information and belief” the source of that asserted knowledge is to be

“specified”¹²³It was not. The affidavit goes on:

The reasons for my proposal were included in the written material, which was part

of a Bureau proposal for amending the Medical Devices Regulations.

[115] There is a document directed to amending the regulations. It is entitled “A Need for

Enhanced Regulatory Control of Invasive Medical Devices.”¹²⁴It first appears in company with

a covering memo dated May 28, 1981.¹²⁵It does not mention the prohibition of Proplast

products. In cross-examination counsel tried to clarify the uncertainty. Counsel suggested that

the proposal for prohibition must be in some other document and Pierre Blais answered:

Q. So that, this, I take it, sir, is a different, because of the timing, a different

proposal or recommendation that you wrote…That's a different one than the one

we looked at that's dated, that's at Exhibit 27, tab 7, from 1981. This is a different

one. Is that right?

A. It -- what you're referring to is probably the first ancestor to the series of

memoranda of which you have one, what we have called the 1981 memorandum.

The -- there was -- we discussed a few minutes ago my preparation of documents

for Dr. Campbell to brief his superior, and it did -- that was the very first of the

documents which ultimately led to many others, including the last one on

ophthalmic products. It was the first ancestor.¹²⁶

[116] There is no series of documents as referred to. The one that was produced does refer back

to the Gordon Conference albeit five years later, as of May 28, 1981:

During the late seventies, Dr. Homsy and his associates made numerous

conference presentations and published a series of papers presenting Proplast

applications and the outcome of clinical studies. All conveyed information which

seemed contrary to basic medical and scientific principles. The findings also had

promotional overtones and were met with scepticism [sic]. At a 1977 conference

¹²³Rules of Civil Procedure R.R.O. 1990, Reg. 194 at R. 39.01(4) and (5)

¹²⁴Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4

¹²⁵Exhibit 27 v. 1 T. 7 and 73 T. 4

¹²⁶Transcript of Pierre Blais (May 10, 2019) at p. 479

Page: 39

of assembled biomedical leaders, pathologists and regulatory affairs specialists,

Dr. Homsy’s presentation was savaged by members of the audience.¹²⁷

[117] The document does not propose the prohibition of Proplast or similar products. Rather it

proposes the following:

In light of the present information, all Vitek, Proplast and Proplast-like implants

should be placed in a special category subject to close supervision by hospital or

professional ethics committees. If adverse events continue to be reported, the

product should be sequestered by the field operations directorate until the

regulatory status is clarified. A similar caveat should apply to any medical

implant based on graphite, glass or other high-performance fibers with or without

a consolidating matrix substance.¹²⁸

[118] Pierre Blais said, in his evidence, that this document was prepared as part of submissions

to be made to Treasury Board. This is confirmed by the covering of memo:

PLASTIC FLUID HANDLING SYSTEMS AND IMPLANTED DEVICES

Rationale for regulatory amendments

Following our discussions with Dr. DasGupta, I have updated the Divisions

rationale for regulatory amendments for our next Project Review.

As requested, I have added a discussion on countermeasures and regulatory

options. Expanded briefings can be drafted for TB [Treasury Board] submissions.

[119] The document appears more than once. Not only is it presented as of May 28, 1981, it

and the memorandum which encloses it, reappear. On the second version the typed date “May 28

1981” is struck out and replaced in handwriting by the date “Feb. 18, 82.” As explained by Pierre

Blais the document was used twice to assist in the preparation of the annual submission made to

the Treasury Board on behalf of the Bureau.¹²⁹The second version has a further handwritten note

asking “Linda” to have the file printed with large type “for Dr. DasGupta’s TB sub”.¹³⁰

[120] These submissions produced a positive result. They led to the amendments to the Medical

Devices Regulations that added to the Schedule to Part V any “new device” designed to be

implanted into the tissues or body cavities of a person for 30 days or more. As already noted, the

amendment was made on October 8, 1982 and became effective on April 1, 1983. Following a

review of the document I asked and Pierre Blais responded:

¹²⁷Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4 at p. 13. There was some confusion as to

whether the Gordon Conference took place in 1976 or 1977. In the end, despite what was said here, it was

determined to have been held in 1976.

¹²⁸Ibid at p. 14

¹²⁹Transcript of Pierre Blais (May 2, 2019) at p. 25-26

¹³⁰Exhibit 27 v. 1 T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4

Page: 40

THE COURT: All right. Now, looking not backwards from that but looking

forwards to where this went ultimately, ultimately, if I understand this correctly,

all of this concern leads in the end to the amendment in the regulation Part V in

1983, in which now we see these kinds of implants, implants that are going to be

input and last for more than 30 [days], becomes part of Part V.

A. Exactly.¹³¹

[121] As it turned out, these three documents, the two versions of the covering memorandum

and the paper, “A Need for Enhanced Regulatory Control of Invasive Medical Devices” are the

second set of documents where the authenticity is challenged. The primary concern with the

paper arises not from handwriting or hand printing but from the type face used. In the early

1980’s modern office machines were beginning to appear. However, Health and Welfare

Canada, as most offices of the day, still used typewriters. This was determined by a review of

documents produced at the time. Typewriters are distinguishable from more modern machinery

as impact printers: the paper is struck by a letter either on an arm or ball. Typewriters utilized

“mono spaced” print. The letters, regardless of their form, take up the same width. The letter “m”

takes up the same space as the letter “i”.¹³²More modern office machines use “proportional

spaced” print. The width of the letters varies.¹³³The printing on the documents was

proportionally spaced. The type face (font) was identified as Helvetica which had existed since

1961 and was based on designs that go back to 1957.¹³⁴This design was not seen on any known

documents with typewritten entries at Health and Welfare Canada.¹³⁵Glyphs (described as

“TM”

“R”

letter/character design) for example

and

were observed to be different from those of

Helvetica and other similar versions. The experts from the Canada Border Service Agency

concluded:

A Helvetica style of typeface was not seen on any known documents with

typewritten entries at Health and Welfare Canada.¹³⁶

[122] They went a step further; they searched typewriter databases to see whether the typescript

on the documents in question could be found in any proportional spacing typewriter. Such

spacing was not common in typewriters at the time. No typeface in any of the identified

classification systems were observed that corresponded to the typed entries being examined. The

glyphs ^“TM”and ^“R”were not commonly available in any typewriters from the time.¹³⁷The experts

found that:

¹³¹Transcript of Pierre Blais (May 10, 2019) at p. 483-484

¹³²Exhibit 74A (Forensic Laboratory Report 27 February 2019) at p. 58 of 84

¹³³Ibid at p. 59 of 84

¹³⁴Ibid at p. 18 of 84

¹³⁵Ibid at p. 19 of 84

¹³⁶Ibid p. 19 of 84

¹³⁷Ibid at p. 19 of 84

Page: 41

Accordingly, no features were observed to indicate that the typed entries depicted

on documents Q2 (1-22) were produced on any typewriter, at Health and Welfare

Canada or available elsewhere, in the time period in question.¹³⁸

[123] The forensic experts also examined the handwriting that appeared on the covering

memorandum. This includes the note asking “Linda” to print the document in larger script, the

handprinted date and the signature “P. Blais”. In each case the determination is the same. The

script tends to be consistent with the specimens of the date shown on the document: it is

“contemporary” rather than “anachronistic”. Thus, these results are different than those

associated with the typed script. However, as a result of the lack of later specimens from the later

time frame the experts do not foreclose the possibility that the hand writing was nonetheless

from a later date than shown on the face of the document.¹³⁹

[124] Obviously, this leaves the situation confused. The handwritten and printed script tends to

the documents being contemporary and the typed script to a later anachronistic date. The experts

acknowledged that while at the contemporary time the typed script was unlikely to have been

produced by a typewriter, there were “commercial printers” that were capable of producing the

script used. Work they had done to establish the equipment utilized by Health and Welfare

Canada, at the time contemporaneous to the dates shown on the face of the covering memoranda,

provided no indication that there was machinery available from contractors involved, who might

have had access to printers with the capacity to produce the script used.

[125] Although not a party to the action, Pierre Blais was examined for discovery. In the course

of this questioning Pierre Blais alluded to the possibility of the printing of these documents

having been done out of the normal context:

In 1982 the printing that you see in your hand is an alien printing. It comes from a

contractor or a machine that was not familiar to me. It was a wizardry of a

computer specialist who essentially reprocessed obsolete medium in order to

extract the original text.

[126] During that examination Pierre Blais referred to a company that he said had a contract

with what was then Health and Welfare Canada “for our word processing system”:

They produced software…and they produced customize systems for correlative

data at National Health and Welfare, and probably other departments as well.

They also did some kind of service on printers. And, they periodically, I think,

loaned us printers, including kinds that I’ve never seen before.¹⁴⁰

¹³⁸Ibid at p. 19 of 84

¹³⁹Ibid at pp. 35-36, 37 and 38 of 84

¹⁴⁰Transcript of the Examination for Discovery of Pierre Blais (February 5, 2019) at pp. 210-212

Page: 42

[127] Counsel for the Crown was quick to point out that, in the absence of the ability to cross-

examine Pierre Blais on these matters this evidence was, at best, hearsay.¹⁴¹However, the

question was not whether it should be accepted for its truth but whether it stood as a suggestion

the experts were aware of as they undertook their work. The forensic expert providing this

evidence was Tobin A. Tanaka. He had read some transcripts before coming to his conclusions.

It was his recollection that he had read of the individuals named in the transcript as associated

with the suggestion that an outside printer could have been involved. Neither he nor the other

expert, R. Brent Ostrum, had conducted any further investigation into this possibility. It was

beyond their mandate. Their concern was as to the physical properties of the documents not their

source, context or content.

[128] If I were required to do so, I would on a balance of probabilities, conclude that these

documents are authentic, that is they are as they appear. The main document “A Need for

Enhanced Regulatory Control of Invasive Medical Devices” is comprehensive dealing with far

more than just Proplast products. Pierre Blais proposed that there were many more versions but

there are only two that appear in the record (1981 and 1982). The two are consistent with the

stated purpose of assisting in demonstrating to Treasury Board that more was required to

properly regulate medical devices. This was apparent from both the overall subject matter and

the timing leading, as it does, to the amendments made on October 8, 1982 and made effective as

of April 1, 1983.

[129] As it is, the value of these documents as providing information supporting a position that

the accepted knowledge about Proplast was such that it should have led inexorably to a

conclusion that products using Proplast should never have been allowed into the market is

minimal if it exists at all. Why is this? It is because Pierre Blais, for all that he is relied on as the

beacon of this idea, acknowledged that amendments to the Medical Devices Regulations that

added implants that were to stay in the body for 30 days to those to be treated under Part V of

those Regulations was a sufficient response to the issues as he saw them. There is no document

demonstrating that a prohibition was ever asked for.¹⁴²There was no need for an absolute

prohibition whether or not one was ever proposed:

THE COURT: And I thought it was -- and you didn't say this before. I just sort

of remembered it when I was trying to work out in my own mind something that

you said. Remember that you said: When we ask for things, I dream; I ask for

everything that I could possibly want, and sometimes all I get is what I need. Do

you remember that?

A. Yes.

THE COURT: And I thought that maybe this fits that understanding of how this

works: You asked for a prohibition, didn't get it but got what you needed because

you got to examine the safety and efficacy of it?

¹⁴¹One of the people referred to “Barbara Goldhamer” was identified by Pierre Blais in his viva voce evidence albeit

for a different purpose (Transcript of Pierre Blais (May 1, 2019) at pp. 100-101)

¹⁴²Transcript of Pierre Blais (May 10, 2019) at p. 484

Page: 43

A. Yes. It was time when we accepted reality.¹⁴³

[130] In fact, it was what he had proposed in the document entitled “A Need for Enhanced

Regulatory Control of Invasive Medical Devices”:

Regulation Amendments are Inevitable

The present medical devices regulations enable inclusion of supplemental device

categories to the list of ‘high risk’ products. Accordingly, case-by-case addition of

specific product categories that embody risks at par or greater than those of the

present classes subject to the provisions of Part V. A timetable setting the date

when each of the new categories become subject to the new requirements would

then be proposed for comment by industry and consumer representatives.

Alternatively, a new set of classification criteria for devices subject to Part V

requirements could be created. It is noteworthy that all, except one, device classes

presently comprised under terms of Part V are implants. …

[131] This was followed by a proposal for the classes of devices that could be added to Part V.

The first of which was:

Missing Major Classes

All of the presently-listed Part V device categories and most classical implants of

other types would be captured under the term “implant”. Thus, a device intended

to be inserted in tissue or a body cavity or expected to be in intimate body contact

for an indeterminate period would become subject to the provisions of Part V. The

issue of contact time is moot. A large body of research and retrospective clinical

studies have demonstrated that direct contact with a faulty device for about a

month is sufficient to impart severe damage to user exposed to an injurious device

that does not have an essential physiologic or mechanical function. The presently

cited “30 day” watershed exposure would thus be retained.¹⁴⁴

[132] This offered the public a level of protection:

THE COURT: Okay, just a minute. So dreaming or dreams includes the

understanding that there would always be a limit on what the regulations would

allow, which I take to mean that there was an acknowledgment that there were

other considerations that regulators would bring to bear on the question which

would probably mean you would not get exactly what you wanted in terms of

regulatory power.

A. Yes, absolutely correct.

¹⁴³Transcript of Pierre Blais (May 13, 2019) at p. 633

¹⁴⁴Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4 at p. 2

Page: 44

THE COURT: All right. And then what you needed was for what you said was

minimal protection, therefore it was something less than the dream, but something

that would provide you with some level of regulatory authority to provide for

some level of protection to the public.

A. Yes.¹⁴⁵

[133] It was a compromise:

THE COURT: Okay, from which I deduced that -- and I'm asking now -- that

what we have here, as you have now described it, is an appearance of a concern,

the evolution of that concern into fear, and a process by which the various

competing points of view worked, ultimately winding up at what you've called a

compromise, which was, in effect, the 1983 inclusion of the 30-day rule, which

would have taken in Proplast and any consideration of it?

A. Exactly.¹⁴⁶

[134] Pierre Blais acknowledged this was typical of how amendments to regulations came to

be. He was asked:

THE COURT: So I want to say again and make sure I have this established with

you, that this is something you understood at the time, that this was a typical

evolution of a regulatory change.

A. Exactly¹⁴⁷

[135] This is not evidence that demonstrates a dedication to the prohibition of Proplast products

but rather the expression of concern, the acceptance of that concern and, in time, the arrival at

what was accepted as an appropriate regulatory response.

[136] The document (“A Need for Enhanced Regulatory Control of Invasive Medical Devices”)

was put to Janice Hopkins. She had been employed at Health and Welfare Canada from 1969 to

1979. She left and went to the Department of Fisheries and Oceans. She returned during 1980 as

the Director, Atlantic Region (Halifax). From 1982 to 1985 she was the Director of Management

Processes working in the Assistant Deputy Minister’s office. She was responsible for, among

other things, how resources were allocated. She and her staff provided the rationale to be put to

Treasury Board for the requests being made. Janice Hopkins does not recall the document (“A

Need for Enhanced Regulatory Control of Invasive Medical Devices”). It needs to be

remembered that she only returned to Ottawa during 1982. More importantly, the evidence

provided by Janice Hopkins confirms the thrust of that paper to the effect that more resources

were required to properly regulate medical devices and their entry into the market in Canada. She

¹⁴⁵Transcript of Pierre Blais (May 1, 2019) at p. 20

¹⁴⁶Transcript of Pierre Blais (May 10, 2019) at p. 486

¹⁴⁷Transcript of Pierre Blais (May 14, 2019) pp. 632-633

Page: 45

identified the minutes of a meeting of the Cabinet Committee on Social Development held on

March 4, 1981, prior to her moving to Ottawa in 1982.¹⁴⁸Apart from the members of Cabinet,

staff from several of the interested government departments were present. This included four

people from Health and Welfare Canada including “Mr. E. Somers” who Pierre Blais said turned

back his recommendation that Proplast be prohibited.

[137] The Committee had for consideration a Memorandum dated February 3, 1981 and

Discussion Paper of the same date, submitted by the Minister of National Health and Welfare,

recommending increased resources for the Medical Devices Program to permit it to more

adequately carry out its responsibilities under the Food and Drugs Act.¹⁴⁹The Minister of

National Health and Welfare opened the discussion. She began by…

… answering a question posed earlier by the Ministry of State for Social

Development regarding other options for dealing with the problem of regulating

the safety and efficacy of imported medical devices. She explained that her

department already uses information from United States regulatory agencies, the

Canadian Standards Council and other reliable agencies but that this alone is

inadequate for improving controls to the necessary level. The proposed approach

is sufficient to deal with the most dangerous devices and usage abuses, but given

the very large number of devices imported from over 30 countries, the rapid rate

of technological change and the sophistication of the technology, it will always be

impossible to check every device type. The provinces help to some degree by

certifying use of certain devices within their territory, but sharing of the work of

testing devices and setting standards could result in fragmented standards and a

fragmented market. She asked to be excused from the study of options requested

by the ministry, since she is satisfied that there are no practical options and that

the only means of reducing expenditures would be to impose a user fee. This

could increase healthcare costs.¹⁵⁰

[138] The Discussion Paper under the heading “RECAPITULATION” summarized the

recommendation being made:

The main points raised in the foregoing are:

Medical devices are essential for modern healthcare but many sold in Canada are

hazardous or ineffective and cause avoidable health or injury.

The Department of National Health and Welfare is responsible under the Food

and Drugs Act for ensuring that manufacturers sell only safe and effective

devices.

¹⁴⁸Exhibit 55 at T. 3

¹⁴⁹Ibid at T. 3, p. 15 and respectively at T. 1 and T.2

¹⁵⁰Ibid at T. 3, p. 15-16

Page: 46

The Department is unable to fulfil this responsibility adequately with present

resources.

Regulatory control of devices in Canada must cope with the unusual situation

arising from the lack of domestic manufacturing the high dependence and demand

for technology by the healthcare delivery system.

A collaborative strategy involving the government, manufacturers and users,

tailored for the Canadian situation, is proposed. This requires 20 PY [person

years] in 1981-82 and an additional 14 PY in the following year for a total of 34

PY to:

(a)

(b)

(c)

Ensure reasonable probability of safety and effectiveness of the

highest priority inventions before open marketing;

develop essential performance and safety standards and testing

capability; and

take corrective and preventive actions in response to report of the

most severe device failures.¹⁵¹

[139] The proposal for a collaborative strategy involving the government, manufacturers and

users was accepted. The Record of Cabinet Decision, dated December 8, 1981, noted:

8. Medical Devices Program

(1) the proposal be approved but the question of additional person years be

considered by the Treasury Board;

(2) the Minister of National Health and Welfare be requested to develop an

overall policy on the question of allocation of costs in relation to testing the safety

of drugs and devices and to report back to the Committee within a year.¹⁵²

[140] The need for additional person years was recognized, the costs acknowledged but

approved. The approval was explained in a letter to the Deputy Minister dated February 24,

1982:

Dear Mr. Fry:

Your minister’s submission seeking resources for an expanded program testing

and evaluation of medical devices was re-considered by the Treasury Board on

February 11, 1982. In addition to the approvals given by the Treasury Board at its

¹⁵¹Ibid at T. 2 (Discussion Paper) at pp. 21 and 22

¹⁵²Ibid at T. 4 (Record of Cabinet Decision) at p. 5

Page: 47

meeting of July 23, 1981, as contained in my letter of July 30, 1981, Ministers

approved the following:

(a)

inclusion of an item in Supplementary Estimates 1982-83 of 20 person-

years and associated salaries of $503,000 for the medical devices program;

and

(b)

an increase in your departments reference levels of 34 person-years and

associated salaries of $855,000 in 1983-84 and subsequent years.

Ministers requested the department to report to the Treasury Board no later than

January 1984 on the appropriate level of service for the medical devices program,

based on information available at the time.

Yours sincerely,¹⁵³

[141] This approach and these considerations demonstrate a recognition of the concerns

associated with the regulation of medical devices. These actions were a substantial effort to

adjust the approach and provide appropriate resources not just with respect to Proplast products

but the broader concern for medical devices at large. This is consistent with the document “A

Need for Enhanced Regulatory Control of Invasive Medical Devices” the content of which went

beyond concern for a single product type and proposed solutions within the regulatory scheme as

opposed to an absolute prohibition of Proplast products. With the October 8, 1982 amendments

in place, the regulatory approach can be seen as collaborative. It relies on:



the manufacturers and distributors to undertake the necessary testing,

the government to consider whether, based on the information provided, a

reasonable probability of safety and efficacy has been demonstrated for the

highest priority inventions (i.e. those to which Part V apply), and



users (doctors, hospitals and patients) to report on difficulties that may appear.

[142] The decision to adopt a collaborative approach was an important one, made at a crucial

moment in the evolution of the policy governing the treatment of medical devices. It is a decision

that informed, modified and explains what happened thereafter in connection with the regulation

and regulatory activity that affected this area of concern.

[143] Those efforts did not stop with those amendments becoming effective as of April 1, 1983.

The record of this trial includes a document dated February 1985, entitled:” Medical Devices

Program, Health Protection Branch, Department of Health and Welfare, Workload Submission”.

It is a proposal to obtain approval to include in the 1985-1986 Supplementary Estimates

¹⁵³Ibid at T. 6

Page: 48

increased funding to allow delivery of the approved minimum level of service for the Medical

Devices Program.¹⁵⁴

[144] This is not to say that over time, from time to time, government demands did not require

adjustment to the resources made available. A letter dated September 26, 1985, from the Minister

of Health and Welfare Canada to the President of the Treasury Board is a case in point. It does

not deal specifically with medical devices. It reads in part:

The updated Multi-Year Operational Plan for my Department is being forwarded

to the Treasury Board Secretariat. As requested this plan incorporates our detailed

proposals for reducing our person-year (PY) requirements over the next five-year.

To achieve the targets proposed to us by the Treasury Board Secretariat.

…

As will be seen in the detailed plan, we have been able to identify a variety of

person-year reductions which will enable us to meet our targets. Indeed, we have

identified possibilities for PY reductions which are considerably in excess of our

targets.

[145] The same letter maintains the concern of the ability of Health and Welfare Canada to

have the resources necessary to undertake its responsibilities:

The MYOP also identifies those areas where we require additional resources to

meet unavoidable workload increases, to carry out new governmental decisions,

and to cover increases in the costs of maintaining a non-discretionary level of

service.

…

However, I do have to put on the record the fact that I am able to offer reductions

of this magnitude only on the understanding that new resources would be made

available to enable me and my Department to meet essential requirements for

which there is no provision in current reference levels, whether these arise from

new government decisions or from unavoidable workload increases. Without this

understanding, clearly I could not make all these cut-backs from departmental

person-year resources, because it would become essential for me to divert

resources to other requirements.¹⁵⁵

[146] This followed a one-person year cut imposed on the Environmental Health Directorate of

which the Bureau of Medical Devices was part, effective April 1, 1984. Of this a 0.33 PY cut

was allocated to the Bureau. At the same time a similar cut of 0.33 PY “temporarily” for the last

¹⁵⁴Ibid at T. 9

¹⁵⁵Ibid at T. 13

Page: 49

few months of 1983-1984 was extended indefinitely.¹⁵⁶To my mind, these are small changes

made in response to policy adjustments that mark the constant evolution of government

priorities. They do not signify any change in the commitment to, or inadequate support for, the

regulation of medical devices.

[147] Through the early 1980’s the regulatory scheme was amended to meet the challenge

posed by the increased interest in, development of and demand for medical devices. The

changes, while not what Pierre Blais says he “dreamed of” as the response to products that

included Proplast, were sufficient to allow for protection of the public. What was the general

understanding of the utility of Proplast and the medical devices in which it was included? It was

not universal acceptance that it was dangerous or that any harm associated with it outweighed

any benefit. In 1983 a book was published¹⁵⁷: “Biomaterials in Reconstructive Surgery.” The

book was edited by Dr. Leonard R. Rubin. Some of his credentials are listed on fronting page of

the book: for example, “Diplomate, American Board of Plastic Surgery; Clinical Professor,

Plastic Surgery, State University of New York, Stony Brook and Director, Plastic [and]

Maxillofacial Surgery and Burn Center, Nassau County Medical Center, East Meadow.¹⁵⁸The

book was described by Pierre Blais as a “teaching textbook on plastic surgery.”¹⁵⁹

[148] Pierre Blais explained to the Court that he had worked with Leonard R. Rubin at the

facilities of the State University of New York in relation to a Proplast chin implant.¹⁶⁰He said

that work demonstrated that part of the Proplast implants had disintegrated and scattered over

about a half-inch of tissue. The implant was surrounded by a layer of pus.¹⁶¹This information

was conveyed to his superiors at Health and Welfare Canada “between ‘79 and ’80;”¹⁶²which is

to say years before the book was published and before the amendment to the Medical Devices

Regulations which added these implants to those devices being treated by Part V.

[149] Leonard Rubin is shown as the author of Chapter 30 of the book, the chapter in which the

work of Pierre Blais is reviewed.¹⁶³It refers to the observation of two patients with mandibular

implants: one placed for 32 years the other for 18 years. These were the tissues evaluated by

¹⁵⁶Ibid at T. 9, p. 6

¹⁵⁷Pierre Blais first testified that the book was published in 1981 (Transcript of Pierre Blais (May 1, 2019) at p. 98)

but the book itself bears the date 1983 (Exhibit 34 v. 1 T. 17 and T. 19) and Pierre Blias subsequently agreed it was

published in 1983 (Transcript of Pierre Blais (May 3, 2019) at p. 404)

¹⁵⁸The complete list found on the fronting page includes: “Attending Plastic Surgeon, Nassau Hospital, Mineola and

Mercy Hospital, Rockville Centre; Honorary Plastic Surgeon, North Shore University Hospital, Manhasset, New

York [and] 1978 Chairman of Gordon Research Conference in Biomaterials.”

¹⁵⁹Transcript of Pierre Blais (May 1, 2019) at p. 98

¹⁶⁰Transcript of Pierre Blais (May 3, 2019) at pp. 399-400

¹⁶¹Ibid at p. 401

¹⁶²Ibid at p. 402

¹⁶³Exhibit 34 v. II T. 98

Page: 50

Pierre Blais. The implants used polyethylene, not Proplast. Pierre Blais acknowledged the work

he did, that is reported in the book, does not consider any Proplast product.¹⁶⁴

[150] To the contrary, insofar as Proplast is concerned, the book suggests something quite

different.

[151] Chapter 31 of the book is entitled “Clinical uses of Proplast: expectations and results”

Pierre Blais said he reviewed the chapter and prepared a critique. He “may have” a copy it but it

was not produced.¹⁶⁵The results of the studies reported in this chapter include:

The extensive amount of experimental animal studies that preceded its use in

humans included the usual small laboratory animals as well as canine and primate

implantations, which later were followed in a few cases much longer than the

usual [illegible] period under the direction of the original experimenters who

continued their observations to their clinical usages. The continued clinical

observation of the implants has allowed interim biopsies, which were quite

desirable. A collation of a total series reported to the manufacturer’s lead to a

review of a series of 900 clinical implantations with the rejection rate of less than

2%.¹⁶⁶

…

Our histological review of these implants and their capsules have shown that all

the implants are surrounded by pore spaces invaded by multinucleated giant cells.

However, we have noted that the population of the giant cells seemed to diminish

with prolonged fibrous tissue in growth though this is based on segmental

biopsies of clinical patients rather than total removal of the implant and its

surrounding tissue reaction for study. Nonetheless, in a few patients because of

gross irregularity or too large a prosthesis, large sections were removed and

studied after several years of insertion and they confirmed the experimental

findings in those primates studied for a period from 3 to 5 years-firm in growth

with adequate fixation.¹⁶⁷

…

Surface fragmentation

There is surface fragmentation, and when the material is examined under a

microscope (Fig. 31-4), one would expect this of a fiber-felt multi-open pored

implant. Bits of surface fragmentation have been found as inclusions in

multinuclear giant cells (Fig. 31-5) nonetheless, the implants have clinically

¹⁶⁴Transcript of Pierre Blais (May 3, 2019) at pp. 409-410

¹⁶⁵Exhibit 34 v. I T. 19

¹⁶⁶Transcript of Pierre Blais (May 13, 2019) at p. 585

¹⁶⁷Exhibit 34 v. I T 19 at pp. 494-495

Page: 51

maintained the initial contour with no clinically palpable detection of the minimal

fragmentation or migration of material. Darkening of the skin, in superficial

locations, such as the nose, the periorbital region, or any area with scar covering

or thin overlying skin with little subcutaneous tissue, by black phagocytized

material has appeared in the dermis can be progressive. This is believed to be a

significant problem in and around the thin tissues and after superficial removal

reoccurrence has been noted, requiring not only the substitution of the Proplast I

with other materials but also, on two occasions, resection of the surface covering.

The migration of material has [illegible] sufficiently serious around the nose and

the periorbital region and one chin to necessitate total removal of implant and its

surrounding fibrous tissue and its initial replacement with either a dermis or

superficial that flap followed at a later date by implementation of other

material….¹⁶⁸

…

SURVEY OF CLINICAL USAGES

The clinical experience over the past 10 years has been reviewed in an ongoing

accomplice and report on more than 900 human implantations with Proplast I that

were carried out internationally by surgeons of various backgrounds using varying

techniques and with varied methods of implant and recipient site preparation. The

use of the implant material was preceded by a 5-year intensive experimental study

of the biocompatibility of Proplast varying anatomic areas and many different

animals, from mice to primates, as well as continuing and repeated studies

biocompatibility in with tissue cultures. In 1973, “The Clinical Use of a New

Porous Implant: Proplast”,” a review of a five-year serial studies of this material

in baboons, was presented to the Association of Plastic Surgeons. In 1975 a 4-

year ongoing clinical study of human Proplast implantations included alveolar and

maxillary augmentation, coating of self-stabilizing condylar prostheses,

mandibular augmentation, soft tissue replacement and reconstruction of costal,

sternal, facial and cranial bone deformities. A survey conducted by Kent et al.,

presented at the International Biomaterials Congress in April 1980, reviewed 700

patients and demonstrated “immediate and delayed” success rates well in excess

of 90%. The literature of the past few years contains reports by experienced

plastic surgeons, maxillofacial surgeons, otolaryngological surgeons, oral

surgeons, and even ophthalmological surgeons, as to the uses and proposed use of

Proplast I. Although all the ophthalmological clinical trials were experimental,

Proplast was well tolerated as implants in the cornea and skilled era and obviously

a good deal has yet to be studied, including the rate of post-tissue in growth in the

long-term acceptance of the alloplast….¹⁶⁹

¹⁶⁸Ibid at pp. 498-501

¹⁶⁹Ibid at p. 501

Page: 52

…

SUMMARY

Proplast has fulfilled to a large degree the criteria that were planned in its original

development; it has a minimal reactivity and is thermostable, and the surface

porosity allows penetration by the adjacent fibroblasts and a certain amount of

tissue fixation. Although relatively easy to shape, there are problems involved

with irregularities, possible feathering of edges, which may, at a later date, flare.

But its low elastic modulus is sufficient to allow gentle massage and external

compression though direct incision and revision of the implant has been carried

out. Except for the one case mentioned, our incidents of infection has been

extremely low. We have had implants that have developed seromas around the

larger sections, possibly because of rib-cage motion during breathing but

eventually tissue fixation has been excellent. We have not seen fixation correlate

with deep penetration, nor have we seen even the long-term cases show a good

bony scaffold. There has been a tendency to fragmentation of the surface with

encapsulation of particles by macrophages, which seem to have migrated to the

dermis. To date this has only been apparent in the superficial dictations below thin

skin flaps or adjacent thin scars. It may be that the light-colored Proplast II may

satisfactorily eliminate this problem, but a further long-term follow-up study is

necessary….¹⁷⁰

[152] This chapter and the studies to which it refers do not confirm that by the early 1980s

there was an understood and comprehensive conclusion that any harm caused by the

implantation of Proplast products would inexorably outweigh the benefits that could be achieved.

[153] The chapter in which this appears was written by Charles Homsy, the developer of

Proplast. Given his expressed concerns, Pierre Blais was asked why the editors of the book (he

was one of them) decided the chapter was worthy of inclusion. The reason? Maybe Charles

Homsy was right:

…collectively in consensus, we decided to err using the logic that was presented

by His Honour. We reasoned: What if Charles Homsy were right; therefore give

him a springboard or maybe a point to express his views and let the rest take place

as it should. We left it to the reader to decide for themselves. That was the

consensus.

THE COURT: But it raises the prospect that it was still believed by the group as a

whole, maybe not all the individual members, that it was still possible that Homsy

was right.

¹⁷⁰Ibid at pp. 507-508

Page: 53

A. Yes.¹⁷¹

[154] According to Pierre Blais this happened well before the book was published. The

decision was taken in 1979, still after the furor Pierre Blais says took place, at the Gordon

conference, in opposition to Charles Homsy.

[155] Dr. Doran Ryan is an American maxillofacial surgeon. He is a teacher and frequent

speaker on the subject. Doran Ryan provided evidence as to the history of the effort to deal with

problems associated with the temporomandibular joint. 1982 was a significant year. There were

advances in the applicable radiology. It had not been possible to inject dye into an area as small

as the temporomandibular joint. This became feasible in 1982 making it easier to identify the

kind of problems involved. Prior to this advance it was difficult to identify the problem when

patients complained of pain or discomfort. In some cases, it was thought to be purely

psychological. In others, more conservative treatment was used: muscle relaxants, anti-

inflammatory drugs, painkillers and other areas of expertise such as neurology. Even with the

improved imaging these “modalities” were still used. Some surgical treatments were undertaken.

Doran Ryan referred to “Dr. Brown” who was taking out the meniscus with a high degree of

success. He had about a 20% failure rate. Beginning in or around 1963, surgeries were

undertaken, where part of the bone was removed and replaced with a block of solid silicone

(described as “gap arthroplasty with implant”). In 1980, efforts were made to reposition the disc.

When it became apparent that repositioning the disc, after displacement, was not always

possible, the disc was removed and solid silicone sheeting used as a replacement. This was

expected to last for years. However, silicone did not have sufficient strength and tended to tear.

A different solution was needed.

[156] As reported by Doran Ryan, the first published results regarding Vitek Proplast Block as

an interpositional implant appeared in 1982, when for example Kiersch reported a 93% success

rate over nine years for 250 implants:¹⁷²

No, no. Vitek did the studies. They have files, a mechanical engineer that did

those studies, and that's what they had. And they also had -- by the time I used

that product in [1983],¹⁷³they already had nine years of experience implanted in

the patients as produced by Kiersch in his study in [1984] that he presented. So,

I'm looking at nine years of history of the product implanted in patients, and also

looked at their bench studies they did on wear of the product…¹⁷⁴

¹⁷¹Ibid at p. 614.

¹⁷²Exhibit 51 T. 10 (Ryan, Doran E: Alloplastic Implants in the Temporomandibular Joint, Oral and Maxillofacial

Surgery Clinics of North America-Vol. 1, No. 2, December 1989) at p. 428

¹⁷³The transcript does not say 1983. It says 1993. The evidence of Doran Ryan was clear. He placed Vitek Proplast

implants from 1983 to 1985. By 1987 he had “explanted” all of these implants. It is my assumption that the

transcript contains a typographical error. In the transcript the Kiersch study is referred to as reported in 1994. The

citation for that study is: “Kiersch TA. The use of Proplast-Teflon implants for meniscectomy and disc repair in the

temporomandibular joint [Abstract]. Presented at the AAOMS Clinical Congress on Reconstruction with

Biomaterials, San Diego, 1984”. Again, I believe the reference to 1994 is a typographical error.

¹⁷⁴Transcript of Doran Ryan (June 4, 2019) at pp. 10-11

Page: 54

[157] In 1984 the American Association of Oral and Maxillofacial Surgeons released a report:

“Criteria for TMJ Meniscus Surgery”. It refers to Kiersch:

Kiersch (1984) reported 250 cases at the AAOMS Clinical Congress using

Proplast-Teflon implants for disk repair or replacement with 93% success over a

nine-year period.¹⁷⁵

[158] There were other indicators of early success. Doran Ryan provided a report in preparation

for testifying at this trial. He referred to studies in addition to Kiersch:

The first published results regarding Vitek Proplast^Rblock being used as an IPI

[Interpositional Implant] appeared in 1982. Wolford and Gallager [sic] reported

on a series of 10 implants followed for 4 years. It was concluded that the

Proplast^Rimplant offered better stability because of the potential for fibrous tissue

growth.¹⁷⁶

…

In 1986 Vitek Inc. conducted a written survey [of] Oral and Maxillofacial

surgeons who performed TMJ joint surgery using Vitek Proplast.^RThe results of

the survey showed that surgeons placed 5070 implants with a 91.5% rate of

satisfaction.¹⁷⁷

…

Moriconi and colleagues in 1986 identified Proplast Teflon as a more predictable

mode of temporomandibular joint reconstruction.¹⁷⁸

…

The August 1988 AAOMS position paper still recognized the use of Proplast

Teflon IPIs in reconstruction of the TMJ.¹⁷⁹

[159] Doran Ryan was referred to a paper by Block, Kent and Homsy which reported a high

degree of success with a polymer Proplast fossa prosthesis implanted in 35 severely damaged

¹⁷⁵Exhibit 51 T. 3 at p. 15; Exhibit 51 T. 1 (Dr. Ryan Expert Report in the Proceeding of Kathryn Anne Taylor v.

The Attorney General of Canada) at p. 023 citing Kiesch TA. The use of Proplast-Teflon implants for meniscectomy

and disc repair in the temporomandibular joint [Abstract]. Presented at the AAOMS Clinical Congress on

Reconstruction with Biomaterials, San Diego, 1984

¹⁷⁶Exhibit 51 T. 1 (Dr. Ryan Expert Report in the Proceeding of Kathryn Anne Taylor v. The Attorney General of

Canada) at p. 023 citing Gallagher DM, Wolford, LM. Comparison of Silastic and Proplast Implants in the

Temporomandibular Joint after Condylectomy for Osteoarthritis. J. Oral Maxillofac Surg 1982;40:627-3)

¹⁷⁷Ibid at p. 023

¹⁷⁸Ibid at p. 023 citing Moriconi, E. Steven, Popowich, Laurence D. Guernsey, Louis H. Alloplastic Reconstruction

of the Temporomandibular Joint; published in Dental Clinics of North America, v30 n2 p 307-325, Apr 1986

¹⁷⁹Ibid at p. 023

Page: 55

joints in 21 patients.¹⁸⁰A retrieval analysis study was conducted in the early 2000’s by the

University of Minnesota School of Dentistry. It was presented at the 68^thAnnual Meeting and

Scientific Sessions of the American Association of Oral and Maxillofacial Surgeons

(AAOMS).¹⁸¹Early results are referred to:

Certain investigators consider that the porous PTFE offered more stability than

nonporous silicone implants. Other desirable properties that were touted were

freedom from adverse reactions, toxillogical safety, rapid tissue in-growth, and

biocompatibility. Early success rates for P/T [Proplast-Teflon] and Silastic

interpositional disk implants were presented at scientific meetings and in the

literature. One retrospective review study of 301 TMJ discectomies replaced with

P/T by Estabrooks et al. showed an overall successful rate of 88.7% over average

follow-up of 33 months. Bee, Gallagher, Cook, and Kiersch all reported success

with the interpositional TMJ P/T implants. In a review of various-up studies of

discectomy using P/T, revealed a mean satisfactory result of 91.5% supporting

their continued use.¹⁸²

[160] This is not the only evidence suggesting that no overall consensus had been arrived at.

Dr. John Orpin was of the view that more and better testing was required. In a letter to Dr. M.T.

Cooper, dated January 17, 1985, he outlined a review undertaken with respect to the

“…Characteristics and Evaluation Criteria for Safety and Efficacy of Orthopedic Implant

Devices”:

100 papers from the literature review, seven orthopedic surgeons were

interviewed, 5 manufacturers were contacted. Characteristics were characterized

into:

(A)

(B)

(C)

(D)

Material properties,

Biomechanical properties,

Interaction with the Body,

Fabrication

Specifically fatigue strength, creep, kinematics, stress, fixation, wear,

implantation, tissue response, degradation, corrosion, surface finish, fatigue

strength were addressed.

¹⁸⁰Transcript of Doran Ryan (June 3, 2019) at p. 70

¹⁸¹Agreed Statement of Facts at para.57 and T. 24 see also T. 23 (“Review of the 1986 Annual Scientific Sessions

Abstracts”)

¹⁸²Ibid at T. 24 (Improving the Management of Patients with Failed TMJ Implants: Retrieval Analysis with

NIDCR’s TMJ Implant Registry and Repository) at p. 1 under heading "Discussion" (citations in original but

omitted here)

Page: 56

The orthopedic surgeons interviewed were not uniformly agreed on assessment

parameters; one felt that no worthwhile test could be performed. Manufacturers

agreed that all the complex tests evaluation of strength fixation methods and

functional characteristics should certainly be performed. Submission evaluations

must by necessity establish a compromise in expecting performance testing of

questionable value and should be expedited as much as possible so as not to

discourage manufacturers from introducing new implants into Canada.

In conclusion the report has achieved the objectives of the contract.¹⁸³

[161] A report written by Christopher K. Ober was made an exhibit to the trial.¹⁸⁴He is the

Francis Norwood Bard Professor of Materials Science & Engineering and Director, Cornell

Nanoscale Facility at Cornell University. His research includes the study of biology-materials

interface and involves investigation of physical, surface and biological properties of many

polymeric materials. His report is an overview presenting a general understanding of Proplast.¹⁸⁵

Under the last heading: “State of Knowledge Regarding Biocompatibility of Proplast^TMbetween

1976 and 1982” Christopher K. Ober says following:

A review of the scientific literature indicates that during the period use of

Proplast^TMimplants continued throughout the 1980’s and only upon FDA recall in

1991 did these implants start to be removed.¹⁸⁶Even today implants of this type

are still in use by some patients.

[162] The fact is that throughout the 1980’s, Vitek Proplast temporomandibular joint implants

were used and recognized by active oral maxillofacial surgeons as a viable and acceptable

treatment.

[163] Dr. Daniel Tomlak obtained his degree in dentistry in 1979 from what was then the

University of Western Ontario and is now known as Western University. He interned at the

Toronto Western Hospital during 1979-1980. In 1980 he entered the maxillofacial surgery

program at the University of Connecticut. Daniel Tomlak regarded the program there as one of

the best available in oral surgery. While there he was trained to do temporomandibular joint

¹⁸³Exhibit 27 v. 3 at T. H (Letter January 17, 1985 (Dr. J.A. Orpin to Dr. M.T. Cooper)

¹⁸⁴Exhibit 8(Expert Report of Dr. Christopher K. Ober, August 24, 2018)

¹⁸⁵This information is provided under the headings: “Definitions of biomaterials, biofunctionality and

biocompatibility”, “Various fluorocarbon polymer materials including Proplast^TM”, “The chemistry and construction

of Proplast^TM”, “Various types of Proplast^TM”, “The differences between the chemical and physical characteristics of

the various types of Proplast^TM”, “The physical properties of the films, sheets, blocks and coatings containing

Proplast^TMthat demonstrate their differences”, “The absence of common elements in the chemical and physical

properties of the various types and forms of Proplast^TM” and “Provide an opinion on the state of knowledge of the

biocompatibility of Proplast^TMPolymers between 1976 and 1982”.

¹⁸⁶Christopher K. Ober cites: Lee, Eisig, and Perrino. Giant Cell Reaction to Proplast\Teflon Implant. J Oral

Maxillofac Surg 2018

Page: 57

implants.¹⁸⁷In 1980, when he entered the program, Proplast was in use in temporomandibular

joint surgery “in some institutions”.¹⁸⁸Vitek Inc. came out with an interpositional material that

was a laminate: “Teflon-Proplast”. It was approved by the FDA in 1983. It was thought to be an

improvement. Its immediate predecessor, silastic implants (a combination of silicone and plastic)

had a high rejection rate. It was expected that Teflon-Proplast would produce better, faster

stabilization than silastic implants. This was part of the knowledge exchange which took place at

roundtable discussions and seminars. The views expressed were positive about Proplast as a disc

replacement. Daniel Tomlak was taught that Teflon-Proplast was safe and effective.¹⁸⁹

[164] In early 1983, after the approval of Teflon-Proplast, Daniel Tomlak went to the John

Peter Hospital in Fort Worth, Texas. While there he worked with Dr. Larry Wolford and Dr.

Bruce Epker. He described them as leaders in the field. They were among the top five oral

maxillofacial surgeons in the United States. They used the Teflon-Proplast laminate implant.

Bruce Epker and Larry Wolford agreed it was the best material for these implants. Larry Wolford

published articles to that effect during 1983.¹⁹⁰

[165] What is apparent from this is that, in the early 1980’s, Vitek Proplast temporomandibular

joint implants were accepted by the top rung of oral maxillofacial surgeons and used by them.

[166] Later in 1983 Daniel Tomlak moved to Thunder Bay. There he worked with Dr. William

Dowhos (who Daniel Tomlak described as the godfather of oral surgeons in Thunder Bay) and

Dr. Eric Orpana. Daniel Tomlak spoke to William Dowhos about the regulatory status of

Proplast. William Dowhos asked him to speak to the head operating nurse about how these

implants could be acquired. The nurse did the research. The product was purchased from its

Canadian supplier, Instrumentarium Inc. Its representative (Lorne Flowers) had a sterling

reputation.¹⁹¹Daniel Tomlak had no discussions about the regulatory status of Proplast. They

were confident because of the reputation of the company and its representative. Daniel Tomlak

testified that throughout his time in Thunder Bay he continued to educate himself. He continued

to review journals and trade publications concerning oral surgery to stay up-to-date and

supplement his existing knowledge. The Thunder Bay Dental Association met regularly and

would discuss temporomandibular joint issues and surgery. He took continuing education

courses.¹⁹²Throughout his time in Thunder Bay (1983 to 1987), as a result of his time in

Connecticut, Fort Worth, Toronto and Thunder Bay he had no hesitation in using Proplast-

Teflon.

[167] In 1986 Daniel Tomlak attended a conference in Vancouver. Proplast-Teflon was not

discussed in any of the keynote addresses, workshops or seminars. None of these formal

¹⁸⁷Transcript of Dr. Daniel Tomlak (May 21, 2019) at pp. 2-4

¹⁸⁸Ibid at p. 4

¹⁸⁹Ibid at p.6

¹⁹⁰Ibid at p. 9. (The following is a paper published in 1982: Gallagher DM, Wolford, LM. Comparison of Silastic

and Proplast Implants in the Temporomandibular Joint after Condylectomy for Osteoarthritis. J. Oral Maxillofac

Surg 1982;40:627-3 and already referred to at fn. 176 herein)

¹⁹¹Ibid at pp. 44 and 47

¹⁹²Ibid at p. 15

Page: 58

proceedings had anything negative to say about Proplast-Teflon. As he recollected it, some

people made favourable comments. But in “hallway conversations” with some American oral

surgeons he was told that they had explanted more Proplast-Teflon temporomandibular joint

implants than had been predicted. There was no mention of bone deterioration; some remodelling

(reshaping of the bone) was both expected and referred to. There was no mention of bone

resorption or fragmentation of the material. Nonetheless, despite the fact that this information

was inconsistent with what he had been taught and what he had noted in his journal review with

respect to Proplast-Teflon laminate, he stopped using it.¹⁹³

[168] From that point he monitored journals and his patients. Daniel Tomlak was hopeful that

what he had learned was an aberration. He recognizes that this is not the case. He did not

immediately see the problem in the literature. It did appear around 1991 although he read about it

later, while in Kingston. He had moved there in 1987.¹⁹⁴

[169] In 1983 Doran Ryan began using Proplast-Teflon. Doran Ryan believes that he and his

three partners implanted 103 patients with Proplast-Teflon IPIs over a three-year period.¹⁹⁵

Problems with Vitek P/T^RIPI, were first noted in 1985.¹⁹⁶Around that time, Doran Ryan started

observing symptoms of bone loss in patients in whom he had implanted the devices. He had an

advantage. Because of his association with a university and its radiology department Doran Ryan

had access to magnetic resonance imaging (MRI). Each of his patients was examined using this

technology. With the implant failing, he took them out (“explanted” them). In March, 1989 he

wrote a Letter to the Editor of the Journal of Oral and Maxillofacial Surgery expressing his

concern:

Unfortunately, Proplast/Teflon does not always withstand the forces generated

within the joint. Gradual wear tends to lead to the development of microparticles

which then lead to a severe foreign body reaction that destroys not only the

condyle but also the temporal bone. The reaction is not self-limiting and can occur

with the clinical symptoms. Many times, the loss of bone is replaced by a giant

cell mass precluding the development of an open bite. Pain, swelling and

limitation of opening tend to be late signs and symptoms, and by the time they

develop the patient has severe bone loss with a defect very difficult to correct.

[170] The letter expresses confidence that Vitek Inc. had undertaken an appropriate evaluation

in receiving its FDA approval:

It appears that Vitek performed the appropriate evaluation of Proplast, received

FDA approval, and marketed a product they felt would be safe, reliable and a

significant advancement that could treat a most complicated disease, internal

derangement of the temporomandibular joint.

¹⁹³Ibid at p. 19-20, 22 and 84

¹⁹⁴Ibid at pp. 34-35

¹⁹⁵Transcript of Doran Ryan (June 3, 2019) at pp. 59 and 76

¹⁹⁶Exhibit 51 at T. 10 (Ryan, Doran E: Alloplastic Implants in the Temporomandibular Joint, Oral and Maxillofacial

Surgery Clinics of North America-Vol. 1, No. 2, December 1989) at p. 429

Page: 59

[171] Doran Ryan was not critical of Vitek Inc. or its intentions:

This letter is not to condemn the Vitek Corporation, in fact, I believe they acted in

good faith. Instead, this letter is an attempt to help prevent serious complications

and to bring a realistic solution to the problem. Proplast/Teflon does not always

fail, but when it does, it can be devastating.¹⁹⁷

[172] In fact, he continued to take part in conferences arranged by Charles Homsy during the

years 1984, 1985 and 1986 held to see how people were doing with his product. As late as 1987

Doran Ryan invited Charles Homsy to take part in a conference, in Lake Tahoe, to discuss

problems with the product.¹⁹⁸

[173] In his Letter to the Editor, Doran Ryan recognized that there were others who saw

Proplast as useful and safe:

This letter is in response to a packet of information sent to the AAOMS

membership from the Vitek Corporation. The information packet contained letters

from oral and maxillofacial surgeons who have used Proplast/Teflon

interpositional implants with great success. These letters appear to defend the use

of the implants and, in general, recommended leaving the implants unless the

patient develops symptoms of failure. All recommended routine to follow-up. It

appears this information was sent to counteract the negative press the product has

recently received.¹⁹⁹

[174] Doran Ryan referenced three articles, one published in 1987, and another in 1990 and the

third in 1992 each of which continued to see Proplast-Teflon implants in a positive light:



in one of the studies 11 of 12 joints with implants showed bony changes, but there

were only a few patients with any symptoms²⁰⁰;

a second study was a multicentre evaluation conducted by Vitek, 86% of 680 P/T^R

were still in place an average of 33 months after placement, and 249 of 584 joints

showed some degree of condylar resorption with only 24 having symptoms²⁰¹;



the third study concluded:

¹⁹⁷Ibid at T. 6 (Letter to the Editor: Journal of Oral and Maxillofacial Surgery, March 1989) at p. 222

¹⁹⁸Transcript of Doran Ryan (June 3, 2019) at p. 72

¹⁹⁹Exhibit 51 at T. 6 (Letter to the Editor: Journal of Oral and Maxillofacial Surgery, March 1989) at p. 222

²⁰⁰Ibid at T. 1 (Dr. Ryan Expert Report in the Proceeding of Kathryn Anne Taylor v. The Attorney General of

Canada) at p. 029 referencing: (Heffez L, Mafee MF, Rosenberg H, et al: CT evaluation of TMJ disc replacement

with a Proplast-Teflon laminate. J Oral Maxillofac Surg 45:657, 1987)

²⁰¹Ibid at T. 1 (Dr. Ryan Expert Report in the Proceeding of Kathryn Anne Taylor v. The Attorney General of

Canada) at p. 029 referencing: (Spagnoli D, Kent JN: Multicenter evaluation of temporomandibular joint Proplast-

Teflon disk implant. Oral Surg Oral Med Oral Pathol 74:411, 1992)

Page: 60

The results of this retrospective study indicate that meniscectomies

with Proplast-Teflon implants are a very effective form of

treatment for TMJ disk dysfunction. Our overall surgical success

rate of 88.7% with an average follow-up period of 33 months

compares favorably with the surgical success enjoyed by Kiersch

with Proplast-Teflon implants.

…

Our experience has shown Proplast-Teflon to be a good

interpositional material when a disk cannot be repaired. ²⁰²

[175] In his report produced in preparation for appearing at this trial, Doran Ryan

acknowledged that there was, in the early and mid-1980’s, no scientific consensus concerning

the use of products using Proplast-Teflon:

Despite my concerns about the Vitek P/T^RIPI, there was no general scientific

consensus on how harmful this product was, and whether all patients who had

received the implant would suffer the symptoms of bone loss that I had

observed.²⁰³

[176] When it is suggested that the regulatory approval of Proplast should have been rejected

out of hand because the risk was clear and accepted, this result conflicts with a historical context

where significant parts of the available literature supported the use of this material, where it had

received approval in the United States (1983), was in use by leading oral maxillofacial surgeons

and where the regulatory scheme put in place, effective April 1, 1983 was accepted by those

inside Health and Welfare Canada as an appropriate means of safe guarding public safety in

terms of protecting patients from harm while providing medical devices that would be of benefit.

[177] There is evidence from a third doctor who implanted patients. This is the evidence of Dr.

Elliot Wayne Tunis.

[178] Elliot Wayne Tunis did not appear. Counsel for the Ontario Health Insurance Plan asked

that a cross-examination of Elliot Wayne Tunis be read into the record. On May 24, 2019 an

order permitting this was made. Rule 31.11(6) of the Rules of Civil Procedure allows that where

a person who has been examined for discovery is unable to testify because he or she has died or

is unable to testify because of infirmity or illness or “for any other reason cannot be compelled to

attend at trial”; a party may, with leave of the trial judge, read into the record all or part of the

evidence given at the examination for discovery.²⁰⁴A cross-examination is not an examination

²⁰²Ibid at T. 1 (Dr. Ryan Expert Report in the Proceeding of Kathryn Anne Taylor v. The Attorney General of

Canada) at p. 029 referencing at fn. 37 (Lewis N. Estabrooks, DMD, Carlton E. Fairbanks, DMD, Russell J. Collett,

DDS, and Lisa Miller, MPH, South Portland, Maine: A retrospective evaluation of 301 TMJ Proplast-Teflon

implants, Oral Surg Oral Med Pathol September 1990) found at Exhibit 51 T. 7 at p. 384 and 385

²⁰³Ibid at T. 1 (Dr. Ryan Expert Report in the Proceeding of Kathryn Anne Taylor v. The Attorney General of

Canada) at p. 028-029

²⁰⁴Rule 31.11(6) taken, in full, states:

Page: 61

for discovery; however, in this case, it was my understanding that Master Haberman had made

an order, the effect of which was to incorporate the cross-examination, albeit in respect of

another action²⁰⁵, into the examination for discovery in this one. (I confess that in the preparation

of these reasons I have been unable to confirm this.) The order allowing the cross-examination to

be read into the record was made on the acceptance of the further understanding, provided by

counsel, that all reasonable efforts had been made to find Elliot Wayne Tunis but without

success. Thus rule 31.11(6)(c) (“for any other reason cannot be compelled to attend at trial”) was

applied and leave granted. In making the order, the considerations found in rule 31.11(7) were

taken into account.²⁰⁶This was a cross-examination but not in the sense that the rule raises. This

was not a situation where the Crown, though a party to the action in which it took place, would

have taken up the sort of examination questioning the contributions that Elliot Wayne Tunis

might make to the action at large. However, the evidence was said to contribute to an

understanding of how the knowledge concerning the impact of these implants evolved over time.

This is undeniably important to this case. The question of weight and probative value remained.

[179] From 1983 to 1987, Elliot Wayne Tunis practiced dentistry “out of the University of

Alberta Faculty of Dentistry”. He went there as a full-time Associate Professor. From 1987 at

least until the date he was cross-examined (February 4, 2009) he was at “South Edmonton oral

surgery”.²⁰⁷

[180] While the cross-examination is not specific, it appears that, during his time in association

with the University of Alberta, Elliot Wayne Tunis implanted a total of 44 patients with 58

Proplast implants.²⁰⁸He started using these implants on an understanding that Proplast anchored

itself and stayed in position much better than Silastic had.²⁰⁹Problems appeared. Implants failed

much earlier than had been expected.²¹⁰A study of the 44 patients was undertaken. The

(6) Where a person examined for discovery,

(a) has died;

(b) is unable to testify because of infirmity or illness;

(c) for any other sufficient reason cannot be compelled to attend at the trial; or

(d) refuses to take an oath or make an affirmation or to answer any proper question,

any party may, with leave of the trial judge, read into evidence all or part of the evidence given

on the examination for discovery as the evidence of the person examined, to the extent that it

would be admissible if the person were testifying in court.

²⁰⁵Willekes v. University of Alberta Hospital et al. 2010 ONSC 1331 (CanLII)

²⁰⁶Rule 31.11(7) states:

(7) In deciding whether to grant leave under subrule (6), the trial judge shall consider,

(a) the extent to which the person was cross-examined on the examination for discovery;

(b) the importance of the evidence in the proceeding;

(c) the general principle that evidence should be presented orally in court; and

(d) any other relevant factor

²⁰⁷Transcript, Cross-Examination of Elliot Wayne Tunis on his affidavit sworn August 1, 2007 at pp. 19 and 23

²⁰⁸Ibid at pp. 7, 8, 19 and 20

²⁰⁹Ibid at p. 68

²¹⁰Ibid at pp. 19 and 23

Page: 62

information provided was limited. It was a small study (58 implants as opposed to several

thousand).²¹¹Those conducting the study did not consider that in circumstances where the

implant was subject to “wear debris and giant cell reaction… the longer it remained implanted,

[these reactions] would increase during the duration of the implant”.²¹²They thought that the

“plastic deformation… was being caused by movement of the joint”.²¹³As it was understood at

the time, it was only some patients where deformation of the implant resulted in shearing away

of wear debris. (“We believe that happened in some of the patients and not in others”).²¹⁴Elliot

Wayne Tunis, and those he was working with, only examined the patients who had the implants

taken out. They had no data with respect to whether or not the wear debris that was being

generated in the explant cases was or was not generated in the patients where the device was not

explanted. They did not know and did not consider this possibility. It was their understanding

that movement of the jaw did not necessarily generate wear debris.²¹⁵

[181] As a result of this work, Elliot Wayne Tunis was of the “feeling” that these implants

carried an unacceptable risk of wear debris leading to giant cell reaction, leading to bony

disruption.²¹⁶This was said in circumstances where they had “…patients that did real well for a

long time”, and had “…patients that did poorly in a very short time”. They did not know what

the difference was.²¹⁷

[182] Elliot Wayne Tunis recommended that using these interpositional implants should be

reconsidered.²¹⁸

[183] Evidently Elliot Wayne Tunis did not feel there was great significance to the work that

had been done. While at a conference he attended, a “poster” was prepared and “put up in a room

and people could wander around and look at it.” Elliot Wayne Tunis did not present a paper

formally outlining the results of the study or his recommendation. He did speak to colleagues and

share his experience with Proplast.²¹⁹The advice he gave the Chief of his department was that

there were “isolated failures”.²²⁰

[184] In the circumstances, I do not give much weight to the evidence of Elliot Wayne Tunis

provided, as it was, through the reading in of the transcript of his cross-examination. The study

he completed was not presented in an authoritative way. What is clear is that its parameters were

limited and its conclusions less than absolute. Some patients experienced real problems, others

seemed to do well. Its recommendation is more suggestive than determinative. No peer reviewed

paper or presentation of the results was published:

²¹¹Ibid at pp. 109-110

²¹²Ibid at p.103

²¹³Ibid at p. 104

²¹⁴Ibid at p. 104

²¹⁵Ibid at pp. 104-106

²¹⁶Ibid at p. 111

²¹⁷Ibid at p. 105

²¹⁸Ibid at p. 109

²¹⁹Ibid at p.111

²²⁰Ibid at p. 33

Page: 63

Q. But as I understood your evidence, what I thought I understood was that

although there were degenerative changes the thinking was not that it was, at the

time, due to the implant?

A. In 1985 we didn’t know the cause of the degenerative changes. We didn’t

know why they were happening, whether it was an implant or something else. We

were just trying to look and see what was happening and then eventually patterns

started to arise, but not for a while.

Q. And did you know any more in February ‘86 or July ‘86 when you presented at

that conference?

A. Well, I think once we had this information we had a pattern established that I

was concerned about. And it didn’t imply that every implant would fail, but that a

certain number had failed in a certain time period. And this was a concern to

me.²²¹

[185] In the midst of this uncertainty, the lack of any true cross-examination by an adverse

party detracts from the weight and value of this evidence.

[186] There was evidence presented that it was years later before there was a more certain or

complete understanding of the harm that is associated with temporomandibular joint implants

that made use of Proplast. Dr. Heather Sheardown is associated with several universities in

Ontario. She is a Professor in the Department of Chemical Engineering at McMaster University,

an Adjunct Professor in the same department at the University of Ottawa and an Adjunct

Professor at the School of Optometry. Although her work has concentrated on the eye with

limited application to weight bearing joints, she has special expertise in biomaterials engineering

and analysis including the response of the body to biomaterials. She has written numerous peer-

reviewed publications on natural and synthetic biomaterials. The majority of her academic work

is concerned specifically with the development, design and testing of new biomaterials, in many

cases for long-term implantation, in the human body.²²²

[187] As part of the evidence she presented at trial, Heather Sheardown provided and reviewed

articles which examined the impact of Proplast implants years after the early and mid-1980’s.

Heather Sheardown referred the Court to a paper published in 1996. The title was: “Morphologic

and Immune Histochemical Observation of Explanted Proplast-Teflon Temporomandibular Joint

Interpositional Implants”. The study was limited to a specific Proplast implant:

The Proplast-Teflon (Vitek, Inc., Houston, TX) interpositional implant (PTIPI),

introduced in 1973, gained widespread use during the early and mid-1980s. The

implant consists of Teflon fluorinated ethylene propylene (E.I. DuPont Co.,

²²¹Ibid at p. 152

²²²Exhibit 50 T. 1 (Curriculum Vitae of Heather Scheardown) and T. 2 (Report of Dr. Heather Sheardown, August

20, 2018)

Page: 64

Wilmington, DE) laminated to Proplast II (Teflon polytetrafluoroethylene and

aluminum oxide).

[188] The paper reviews the placement and expectations for the implant:

The Proplast surface is placed toward the glenoid fossa to allow ingrowth of bone

and fibrous tissue into its porous structure to increase implant stability; the

smooth Teflon surface faces the articulating area of the condyle.

[189] The Abstract that introduces the paper states its purpose:

Purpose: The objective of this study was to investigate the cellular tissue response

to temporomandibular joint (TMJ) Proplast-Teflon disc material by morphologic

and immunohistochemical means.

[190] The Abstract cites the conclusion reached:

Conclusions: The study of the PTIPI-induced tissue reaction gave no indication of

a toxic or an immunologic pathogenesis. Mechanical stress seems important in the

fragmentation of the implant and induction of the foreign body reaction. It is not

yet known if this fragmentation is the major contributing factor.²²³

[191] Heather Sheardown also referenced a paper from 2008: “Evaluation of Surgically

Retrieved Temporomandibular Joint Alloplastic Implants-Pilot Study”. It identified the product

(Proplast), the problem (fragmentation) and the regulatory response that had been implemented

but made clear there was still not a complete understanding of the mechanisms in play:

In the late 1980s, Proplast/Teflon TMJIP were found to brake [sic] or be rejected

in many patients, because of the high biomechanical force placed on them ^{[a series of}

^{footnotes are referred to]}The break down led to production of fragmented particles which

[more footnotes]

resulted in an immune foreign body response

causing problems

ranging from severe cutaneous inflammatory reaction in the pre-auricular and

cheek areas ^{[another footnote]}; to severe degenerative joint disease with resorption and

erosion of the TMJ bony structures, perforation into the middle cranial fossa ^[three

more

^footnotes], chronic pain, increased joint noises, TMJ hypermobility, and

malocclusion. The result was a dramatic clinical spectrum of failures for these

[More footnotes referred to]

implants.

The December 1991 issue of the US Foods and

Drugs Administration Bulletin recommended immediate removal of all previous

TMJ Proplast/Teflon^RIPs, June 2 mechanical failures, resulting in progressive

[two additional footnotes]

bone degeneration.

The American Academy of Oral and

²²³Exhibit 50 at T. 8 (Ida Gjessing Trumpy, MD, DDS, MHA, Borghild Roald, MD, Phd, and Torstein Lyberg, MD,

DDS, Phd; Morphologic and Immune Histochemical Observation of Explanted Proplast-Teflon Temporomandibular

Joint Interpositional Implants, J. Oral Mavillofac Surg 54:63-68, 1996) at p.63

Page: 65

Maxillofacial Surgery (AAOMS), in a 1992 workshop, mandated the

discontinuation of Proplast/Teflon^RIPs.²²⁴

[192] The paper demonstrates that, even in 2008, those involved were learning about the shape,

size and danger of the particles that resulted from fragmentation of the implant. There were three

paragraphs making up the “SUMMARY AND CONCLUSIONS” of the paper. The first notes:

This pilot study demonstrated that pain was a significant correlate to perforation

of the alloplastic TMJ IP implants. This finding has been speculated elsewhere ^[two

footnotes]

but it is scientifically demonstrated here for the first time. Patients with

these TMJ implants devices report difficulties in tolerating their pain symptoms.

Moreover, Teflon materials present in these implants appear to structurally fail

and cause a FBGCR [Foreign Body Giant Cell Reaction] in the TMJ. The cause

of this breakdown may be multifactorial.

[Emphasis added]

[193] This conclusion demonstrates that those interested in the area were still learning and that

there was more to learn. The second of the three paragraphs suggests better techniques were

being developed to assist in this work:

Stereo zoom microscopy may constitute a good quality technique to investigate

biomechanical failure patterns on the surface of implant devices. Electron

Microprobe analysis (with line profile and element mapping) can be an

appropriate procedure to evaluate the surface of implant devices, analyze the

quality and quantity of different chemical phases present.

[194] The third paragraph observes:

Of this pilot research also provided new information on the problems associated

with past implant materials, and these findings may assist in developing other

appropriate types of TMJ implants materials more resistant to perforation and

breakage. These new TMJ materials should be biocompatible and able to resist to

TMJ biomechanical forces, without producing wear debris.²²⁵

[195] The search for materials that would perform without fragmentation (wear debris)

continued.

[196] This continuing search for answers and the evolutionary nature of the understanding and

knowledge, as reflected in this paper, was recognized by Doran Ryan:

²²⁴Ibid at T. 9 (Joao N.A.R. Ferreira, DDS MS, Ching-Chang KO, DDS MS Phd, Sandra Myers, DMD, James

Swift, DDS, James R. Fricon, DDS; Evaluation of Surgically Retrieved Temporomandibular Joint Alloplastic

Implants-Pilot Study J Oral Maxillofac Surg. 2008 June; 66(6):1112-1124) at p. 2

²²⁵Ibid at T. 9 (Joao N.A.R. Ferreira, DDS MS, Ching-Chang KO, DDS MS Phd, Sandra Myers, DMD, James

Swift, DDS, James R. Fricon, DDS; Evaluation of Surgically Retrieved Temporomandibular Joint Alloplastic

Implants-Pilot Study J Oral Maxillofac Surg. 2008 June; 66(6):1112-1124) at p. 8

Page: 66

THE COURT: Sorry, I just want to clarify something. Just a minute. You said that

in what I understand to be a fairly absolute way, and I just want to confirm my

memory from yesterday, that yesterday the proposition was that the body was… I

thought the proposition was that there are some kinds of particles that the body is

capable of absorbing and dealing with either, I think you said, it can flush them

out through the flow of bodily fluids is one option. The other option was that the

body naturally encapsulates the particle and, in effect, separates it from the rest of

the body and, therefore removes any harm. There are some particles that that can

happen with. There are some particles that that cannot happen with, and I believe

you said that the particular problem or a particular problem associated with the

particles that broke away from the Proplast was that they had jagged edges and,

therefore, any effort by the body to encapsulate them would fail because it breaks

up the encapsulation and, therefore, leaves the body exposed to the particle. Have

I got that right?

A. Your Honour, yes, that’s correct.

THE COURT: What I take from that, therefore, is that what happened here is that

the body’s protection—

I don’t want to say, protection. Efforts, I’m not sure that’s the right word.

Protection tools…

MR. NEWLAND: Self-defence.

THE COURT: Self-defence. Didn’t function with respect to these particular

particles?

A. Yes

THE COURT: Just to be clear about this in the context I’m putting this into, we

did hear some evidence from another witness that there was a paper written as late

as 2008 which in some fashion—I don’t think I’ve read the paper but she talked

about it. Some fashion, examined that question and noted, for example, that the

particles were, I think jagged edged, and I think quite large. I think that was the

other proposition.

A. Yes it was.

THE COURT: My point being, it would appear from that, at least from my

perspective that the literature surrounding this question was developing over time

to the point where it was still being looked at as late as 2008. Do you know that?

A. yes

Page: 67

THE COURT: Okay, thanks.²²⁶

[197] I return to an observation made earlier in these reasons. Science does not tend to develop

its understanding in moments of insight or clairvoyance. These understandings develop over

time. It is the position of the Plaintiff that as a result of the work of Daniel Tomlak, Doran Ryan

and Elliot Wayne Tunis the dangers of Proplast should have been clear to the point where there

should have been no granting of any Notice of Compliance. Daniel Tomlak’s decision to stop

arose not from any paper or study referred to at the conference he attended. It was a hallway

conversation; not one where bone deterioration was raised. The concern was that more of these

implants had been taken out than had been predicted. I have already indicated that I do not give

much weight to the evidence of Elliot Wayne Tunis. The study he undertook was small and

limited. Its conclusions were not determinative and no peer reviewed paper or presentation was

published or brought forward. Doran Ryan stopped implanting Proplast products but continued

to inquire. The letter he wrote in March, 1989 to the Editor of the Journal of Oral and

Maxillofacial Surgery demonstrates his view at that time. Unhappily and for whatever reason the

quotations relied on by the Submissions of the Plaintiff only quote those parts that indicate the

concern, not those that explain Doran Ryan’s overall view. These quotations do not indicate:



the acknowledgement that Vitek Inc. had acted in good faith,

the purpose of the letter as an “attempt to help prevent serious complications and

to bring a realistic solution to the problem”,



the understanding that Vitek Inc. had performed the appropriate evaluation of

Proplast,



that there were letters that appeared to defend the use of the implants,

in general, recommended leaving the implants unless the patient develops

symptoms of failure, and



that articles continues to be published that saw Proplast in a positive light.

[198] The importance of the article of 2008 referred to by Heather Sheardown (“Evaluation of

Surgically Retrieved Temporomandibular Joint Alloplastic Implants-Pilot Study”) is not, as the

Submissions of the Plaintiff would have it, to advocate that the regulator required “…scientific

consensus or worse still certainty before conducting a recall”.²²⁷Rather it is to show that the

scientific understanding remained incomplete. That the work continued, even 18 years after the

recall of all Proplast products. I repeat science tends to evolve and, generally, is not subject to

moments of comprehensive understanding.

[199] I have not as yet said anything concerning the substance of the evidence provided by

Robert Pilliar. He testified that the “steps” that complete the understanding of the problems with

²²⁶Transcript of Doran Ryan (June 4, 2019) at pp. 27-29

²²⁷Submissions of the Plaintiff at para. 74

Page: 68

Proplast were identified and understood as long ago as 1963. That is years before the formation

of the Medical Devices Bureau. The foundation for this understanding is what counsel for the

Plaintiff described as a “paper” written by Dr. John Charnley in that year. It was not a paper. It

was a “letter to the editor” published in The Lancet on December 28, 1963.²²⁸It was not peer

reviewed. It is said to be a “warning against the use of P.T.F.E. where abrasion with the

liberation of particles is likely”.²²⁹There is no demonstration of the evidence upon which this

“warning” is founded but there is a statement that “the paper on this subject” will likely not be in

print for another two years. The promised paper was published in 1969.²³⁰

[200] Robert Pilliar acknowledged that John Charnley’s letter to the editor included statements

that contained a measure of speculation. Considered alone one could not extrapolate any

conclusions about the temporomandibular joint.²³¹The 1969 paper reported on an analysis of

PTFE [Teflon] wear debris from different sized implants used in hips. Robert Pilliar agreed that

the temporomandibular joint and hip joints have a “completely different geometry”, which meant

that the conclusions reached with respect to the use of Teflon hips were not directly transferable

to the temporomandibular joint.²³²As it is the replacement hip joints functioned very well.²³³

Robert Pilliar also acknowledged that John Charnley appeared to conclude that the release of

small amounts of PTFE was not intrinsically harmful to patients.²³⁴Robert Pilliar agreed that

these questions raised concerns about the conclusions suggested as having been raised in the

paper attributed to John Charnley:

THE COURT: I want to now just go back and pretend we’re reading this in 1968

and propose to you that relying on this work in a – as if we had a finished

conclusion about the validity of these TMJ joints would have been, to put it

kindly, speculative, but this just doesn’t support, it seems to me at the moment,

that kind of conclusion.

²²⁸Exhibit 10

²²⁹Exhibit 10 at p. 1379 and Transcript of Robert Piliar (April 10, 2019) at p. 52

²³⁰Exhibit 11

²³¹Transcript of Robert Pilliar (April 10, 2019) at p. 44

²³²Ibid at p. 84 and 86

²³³Exhibit 11 (John Charney 1969 paper) at p. 35: Under the heading “The biological cause of failure” there is the

observation that while there appeared to be some problems:

…these artificial hips functioned very well even with the plastic socket grossly worn

²³⁴Transcript of Robert Pilliar (April 10, 2019) at p. 82 and see Exhibit 11 (John Charney 1969 paper) at p. 35:

It would appear that P.T.F.E. proved unsuitable for this type of surgery because it produced

particulate matter too fast for the tissues to dispose of it. In small amounts there seems nothing

intrinsically harmful in particles of P.T.F.E. since we have many instances of this material in

human tissues where it becomes sealed off and later becomes calcified, over a period of seven

and eight years.

Page: 69

THE WITNESS: I agree.²³⁵

[201] A review of the paper demonstrates that it would have been wrong and speculative to rely

on it as a confirmation that these kinds of prosthesis should not be used and were dangerous.

[202] This being so it is apparent that no definitive conclusion as to the impact and effect of

Proplast temporomandibular joints was available in 1963 or 1969. The idea that somehow more

was known than this evidence suggests would be contrary to the collective evidence of all of

Doran Ryan, Daniel Tomlak, Elliot Wayne Tunis, Heather Sheardown and a proper appreciation

of what was said by both Pierre Blais and Robert Pilliar. An example of what was left to be

learned is the question of whether and to what extent the temporomandibular joint is weight

bearing. Whether it is weight bearing and how the load is distributed impacts the tendency of

particles to break away. Robert Pilliar acknowledged that even in the 1980’s there were oral

surgeons who did not believe that the temporomandibular joint was weight bearing.²³⁶Even

today while the presence of loading is generally accepted there remains some question as to the

actual impact. Doran Ryan testified that compressive load is not directly into the joint itself but

on the articular eminence, and that to this day no one really knows how much load is placed on

the temporomandibular joint.²³⁷Elliot Wayne Tunis, in the cross-examination admitted as

evidence, testified that as of 1986 oral surgeons did not consider temporomandibular joints to be

weight bearing.²³⁸

[203] Robert Pilliar’s core conclusion, as relied on by the Plaintiff, is found in an affidavit he

swore on October 11, 2000:

A reasonable and professionally trained scientific reviewer in 1975 should have

questioned the use of these materials (silastic [silicone], proplast, Teflon or

acrylic) as bearing services for joint replacement applications, including TMJ, and

would have requested appropriate testing to improve the efficiency and durability

of these materials for such applications.

[204] It may well be that in 1975 there was more to be learned about the processes both

mechanical (the working of these devices) and human (understanding the body’s response). The

tracing of the history suggests that this is exactly what happened. The Court was presented with a

paper by Mark G. Fontenot and John N. Kent which, in its opening paragraphs, provides a short

view of the evolution of what had been learned. Fontenot and Kent realized that there was little

reporting on the problems with Proplast TMJ Disc Implants and, therefore, undertook their study

which was reported in 1992.²³⁹The paper begins with the historical overview:

²³⁵Ibid at pp. 82-87

²³⁶Ibid at pp. 10, 42-43

²³⁷Transcript of Doran Ryan (June 3 2019) at pp. 53-54

²³⁸Transcript, Cross-Examination of Elliot Wayne Tunis on his affidavit sworn August 1, 2007 at p. 104

²³⁹Exhibit 9 (Fontenot: Mark G., Kent, John N.: “In Vitro Wear Performance of Proplast TMJ Disc Implants”, J.

Oral Maxillofac Surg 50: 133-139, 1992) at p. 133

Page: 70

1. 1970 Interpositional Implants using Teflon were in place. There was early and short-term

success;²⁴⁰

2. by 1983 hundreds of implants were put in place; by 1986 it was thousands;²⁴¹

3. in 1986 reports began describing biomechanical failures… that caused adverse tissue

reaction and bone resorption;”²⁴²and

4. in 1986, at an annual meeting of the American Association of Oral and Maxillofacial

Surgeons the presence of debris was identified. “Several clinicians reported

biomechanical failure of both Proplast I and II laminated to Teflon FEP used as disc

replacement in patients and animals.”²⁴³

²⁴⁰See footnote 3 to the Fontenot paper. This success was reported in Kiersch TA. “The use of Proplast-Teflon

implants for meniscectomy and disc repair in the temporomandibular joint [Abstract]. Presented at the AAOMS

Clinical Congress on Reconstruction with Biomaterials, San Diego, 1984”. The Fontenot and Kent paper begins

(and leads to the footnote) with:

In the early 1970s, Teflon FEP (fluorinated ethylene propylene; E. I. Dupont De Nemours & Co,

Wilmington, D.E.) film was laminated to porous Proplast I (Teflon polytetrafluoroethylene

[PTFE] and carbon; Vitek Inc., Houston, TX) and short-term success was subsequently reported

using this sheeting as a temporomandibular joint (TMJ) condylar cap without disc removal.

Based on these early successes….

[Emphasis added]

The Fontenot and Kent paper goes on to refer to the paper by Kiersch:

This Proplast-Teflon interpositional implant (PTIPI; Vitek, Inc., Houston, TX) was used as a

TMJ disc replacement and Kiersch was the first to report on its successful use.

²⁴¹Exhibit 9 (Fontenot: Mark G., Kent, John N.: “In Vitro Wear Performance of Proplast TMJ Disc Implants”, J.

Oral Maxillofac Surg 50: 133-139, 1992) at p. 133:

In the United States, the use of interpositional TMJ implants for disc replacement, primarily

silicone rubber (Silastic; Dow Corning, Midland, MI) and PTIPI, escalated from hundreds

annually in 1983 to thousands by 1986.

²⁴²Ibid at p. 133:

However, reports begin describing biomechanical failure of the PTIPI that caused adverse tissue

reaction and bone resorption in both animals and humans.

²⁴³Ibid at p. 133:

At the 1986 annual meeting of the American Association of Oral and Maxillofacial Surgeons

(AAOMS), several clinicians reported biomechanical failure of both Proplast I and II laminated

to Teflon FEP used as disc replacement in patients and animals.

Page: 71

[205] It may be that through the lens of hindsight all seems clear, at least to some people. It was

not so at the time. The evidence demonstrates continued learning through the 1980’s and beyond.

The paper written by Mark G. Fontenot and John N. Kent was published in 1992 but, even then,

does not definitively pronounce the end of the utility of Proplast TMJ disc implants. The abstract

for the paper was as follows:

This study investigates the in vitro performance of Proplast-Teflon Interpositional

Implants (PTIPI: Vitek, Inc., Houston, TX), employing a mechanical TMJ

simulator. Predictions of in vivo service life of PTIPIs are presented based on the

in vitro wear testing data. Commonly employed laboratory testing methodologies

are discussed in the development of alloplastic TMJ devices. Penetrative wear

rates of the PTIPI at a 20-lb (9.1 kg) load were calculated to be 2.29 mm/100,000

cycles, yielding a predicted in vivo service life of PTIBIs of approximately 3

years. These results combined with reported clinical fate of this implant indicate

that the intermediate-and long-term survival of this implant are uncertain.

[Emphasis added]

[206] Even so, I do not wish to be taken as saying it is only when knowledge is comprehensive

and complete that the concern can be of a degree calling for a regulatory response. That can

come earlier. The American Academy of Oral and Maxillofacial Surgery (AAOMS) convened a

conference in November 1992 - of which Doran Ryan was one of the organizers - to determine

what parameters of care should apply to patients who had received temporomandibular joint

implants. The conference consisted of a comprehensive review of the relevant literature.²⁴⁴At

the conference, the AAOMS developed a consensus position that the use of Proplast-Teflon IPI’s

should be discontinued because it was an inappropriate material for this purpose. However, even

at this stage there was a lack of consensus in terms of whether Proplast-Teflon IPI’s needed to be

removed in asymptomatic patients.²⁴⁵A minority believed that this was not necessary. During

October 1993, the AAOMS’s published “Recommendations for Management of Patients with

Temporomandibular Joint Implants” in the Journal of Oral and Maxillofacial Surgery based on

the consensus positions raised at the November 1992 conference. It was only at this time that a

consensus was reached in the oral and maxillofacial surgical community about the risks

associated with the use of Proplast-Teflon IPI.²⁴⁶

THE APPLICATIONS FOR NOTICES OF COMPLIANCE

[207] The evolution of the understanding of the harm as opposed to the benefit of the

Proplast²⁴⁷temporomandibular joint implants being as I have described, there could be no clear

or preordained outcome to any submissions made seeking the issuance of Notices of Compliance

for these products. To my mind, this is where the central issue in this case arises. How were

²⁴⁴Agreed Statement of Facts at para. 76; Transcript of Doran Ryan (June 3, 2019) at pp. 92-93; Exhibit 51 T. 12

²⁴⁵Transcript of Doran Ryan (June 3, 2019) at pp. 92-100; Exhibit 51 T. 12 at p. 1166

²⁴⁶Agreed Statement of Facts at para. 78; Transcript of Doran Ryan (June 3, 2019) at pp. 98-99; Exhibits 51 T. 12

and 8 at p. 46

²⁴⁷Submissions of the Plaintiff at para. 27

Page: 72

these applications dealt with? Were they analyzed as the Medical Devices Regulations required?

Is there a demonstrated duty of care owed to any members of the class in the conduct of the

evaluation and determination as to whether any Notice of Compliance should be issued? As it is,

these applications were, for the most part, rejected. On this basis there is little room or reason for

the Plaintiff to complain about the considerations brought to bear by the representatives of the

Crown.

[208] The first of two series of applications was made, that is, material was received by Health

and Welfare Canada, on or about March 17, 1987.²⁴⁸The substance of the test and the process

was set by the amendment to the Medical Devices Regulations which became effective April 1,

1983. Prior to that date all that would have been required was a notification to Health and

Welfare Canada of the intention to import and market the product in Canada. In such a situation

it would have been open to the Crown to request the studies that had been done to support the

marketing of the product. In this case, the Plaintiff asserted, and the Crown acknowledged, that

no such notification had been provided. In the period following April 1, 1983 there were two

mechanisms available through which a medical device included on the schedule associated with

Part V of the Medical Devices Regulation could be permitted for sale in Canada. The first would

apply if it could be shown that the product had been sold here prior to the effective date of the

revised regulations. This is what was referred to as “grandfathering”. The Crown readily

acknowledged that it could not rely on this as a means by which the Vitek Proplast products were

or could have been sold in Canada. The Vitek Proplast implants required a Notice of

Compliance, the second of the two mechanisms.

[209] On January 12, 1983, in preparation for the coming into effect of the amended Medical

Devices Regulations, the Health Protection Branch of what, at the time, was still known as

Health and Welfare Canada, issued an Information Letter.²⁴⁹It was distributed to “Manufacturers

and distributors of Medical Devices” and to “Hospital Administrators”. It was further to an

earlier Information Letter that had been issued on June 21, 1982 which had proposed the

amendments “to modify the table to Part V to include the devices designated for implantation

into the tissues or body cavities of a person for thirty days or more.”²⁵⁰This further Information

Letter outlined the expectations for submissions that were to be made:

The requirements of Part V apply only to ‘new devices’ as defined in the

regulations. For these, the manufacturer must submit the required information in a

reasonable format for evaluation. Publication 82-EHD-55 “Guideline to Part V of

the Medical Devices Regulations”, designed to aid in the preparation of a

submission, is available upon request. …

[210] And the impact and meaning represented by the granting of a Notice of Compliance:

A notice of Compliance [sic] issued by the Branch after evaluation of the

submission does not signify approval. It does, however, provide users with the

²⁴⁸Exhibit 12 T. 4 (Submission Control Form)

²⁴⁹Exhibit 19 (Information Letter No. 638)

²⁵⁰Ibid (Information Letter No. 638 referring to Information Letter No. 625)

Page: 73

assurance that the Branch is satisfied that the manufacturer has carried out tests

and has submitted appropriate results to demonstrate a reasonable probability of

the safety and effectiveness in humans. The onus of ensuring safety and

effectiveness of the device remains with the manufacturer.

[211] And concludes with the following:

Since all new devices will not be labelled to indicate that the products have

received Notices of Compliance, purchasers of these devices may obtain

information about the status of the device by writing to…[Address provided] ²⁵¹

[212] What this Information Letter did was to confirm the fundamental responsibilities of each

of the parties to the collaborative process referred to by Janice Hopkins: the provider of the

product (the manufacturers and distributors) was required to do the studies and demonstrate the

safety and efficacy of the new device; the government (the regulator) confirmed that tests had

been done and appropriate results demonstrated and users (the hospitals) were left to confirm for

themselves that a Notice of Compliance had, in fact, been issued. The significance of the

recognition that the granting of a Notice of Compliance was not an approval is that this process

did not provide an assurance that the product was safe and effective; only that there was a

reasonable probability that it was. Any decision as to its use for any particular purpose was left to

the user, the medical professional.

[213] It should not be forgotten that there are competing values that need to be balanced. The

desire to provide products of benefit to those that are ill, challenged, impaired or in pain but to do

so within an acceptable degree of risk.

[214] Quite apart from the general efforts made to advise those interested of the new

requirements and procedures there was some specific communication and advice given to Vitek

Inc. On May 10, 1983 (that is to say, one month after the implementation date of the amendment

to Part V of the Medical Devices Regulations) the Medical Devices Bureau received a letter from

Vitek Inc. advising that the company was planning to export three unapproved non-

temporomandibular joint Proplast devices to Canada. Vitek requested a letter from Health and

Welfare Canada stating that the import of these devices into Canada was permitted and was not

contrary to Canadian law.²⁵²By letter dated May 17, 1983, Health and Welfare Canada

responded. The devices in question were subject to Part V of the recently amended Medical

Devices Regulations. Vitek Inc. was advised that Notices of Compliance were required before

these devices could lawfully be sold in Canada and, accordingly, that evidence regarding the

safety and efficacy of the devices was to be provided. The letter enclosed a copy of the Part V

Submission Guidelines and a copy of the Medical Devices Regulations.²⁵³On May 25, 1983,

Storz Instrument Company, an American distributor of Proplast implants, wrote to the Medical

Devices Bureau. The letter was an attempt to provide notification of the Proplast-based devices,

²⁵¹Ibid (Information Letter No. 638)

²⁵²Agreed Statement of Facts at paras. 81-82 and T. 50; Exhibit 14 at p. 57

²⁵³Ibid at paras. 83 and T. 51; Exhibit 14 at p. 56

Page: 74

presumably to avoid the requirements of Part V.²⁵⁴In a further letter, this one dated October 31,

1983 Health and Welfare Canada reiterated that these products could not be sold, in Canada,

without a Notice of Compliance.²⁵⁵A further copy of the Part V Submission Guidelines and the

Medical Devices Regulations were enclosed. It was not until the submission received by Health

and Welfare Canada on March 17, 1987, that any application seeking Notices of Compliance for

Proplast products was made by Vitek Inc. or anyone else on its behalf.

[215] Nirmala Chopra began her career in England. In 1970, she joined Health and Welfare

Canada. In 1976, shortly after its formation, she moved to the Bureau of Medical Devices and, in

1979, was put in charge of pre-market review. She was there through 1983, when the amended

regulation was put in place. As a technical matter she remained in that position until 1990 when

she left due to a disability. In fact, during 1988 she was seconded to a department dealing with

the AIDS epidemic and did not return.

[216] Almost from the outset there were concerns with respect to the ability of the Bureau of

Medical Devices to review and respond to the demand that followed the implementation of the

amendments to the Medical Devices Regulations. On November 13, 1985, there was a meeting

of the “Dental Task Force”. The Minutes reveal that those present, which included Nirmala

Chopra, considered an article she had written that was being proposed for publication in the

Canadian Dental Association Journal. Among other things, the article referred to the volume of

available devices:

Advances in various fields of Science and Engineering in recent decades have

resulted in the availability of a wide variety of medical devices for therapeutic and

diagnostic purposes. There are roughly 320,000 devices comprising

approximately 100,000 trade names. These devices are manufactured by 2500

manufacturers of which approximately 20% are Canadian.

Most devices used in Canada are imported from 35 countries with the majority of

these being from the United States. Controls in these countries vary from virtually

no regulations or controls to others [that vary] greatly in extent.

[217] The benefits and competing risks were made apparent:

Although there is no doubt that devices have improved the health and well being

of the public and reduced morbidity and mortality, there are also reports atributing

[sic] morbidity and mortality to hazardous and ineffective devices.

[218] The paper goes to observe that different classes of devices may, in turn, be treated

differently:

In addition to these general regulations, certain classes of devices are subject to

greater regulatory controls. These controls fall into two categories - premarket

²⁵⁴Exhibit 16 at p. 119

²⁵⁵Agreed Statement of Facts at para. 84 and T. 52; Exhibit 16 at p. 114

Page: 75

review and the establishment of standards. The criteria for requiring some device

classes to meet standards may be quite different to criteria for requiring premarket

review. ²⁵⁶

[219] Apprehensions surrounding the regulation of certain devices were raised. The responses

were in line with the understanding of distinctive treatment. Concerns had been expressed

regarding “dental implants” and the fact that they all required the issuance of Notices of

Compliance under Part V of the Medical Devices Regulations as it had been amended:

All dental implants and restorative materials came under definition of “Implants”

and were subject to premarket review. However, representations were received

from the dental industry seeking clarification of the status of certain restorative

materials.

[220] In response to those representations, on October 9, 1985, the Health Protection Branch

published Information Letter No. 696 to “Manufacturers Distributors of Dental Devices”:

Dental Implants

The Medical Devices Regulations were amended, effective April 1, 1983, to

require premarket review of all devices designed to be implanted into the tissue or

body cavities of a person for 30 days or more.

Representations have been received from the dental industry seeking clarification

of the status of certain dental restorative materials insofar as premarket review is

concerned. As a result of discussions with representatives of the Canadian Dental

Association, the Dental Industry Association of Canada, and the Canadian

Association of Manufacturers of Medical Devices, it has been decided that dental

materials defined as those devices attached only to non-vasculararized tissue or

the oral cavity having no direct access to systemic or lymphatic circulatory

systems will not be treated as implants.²⁵⁷

[221] This was not the only expressed concern. An earlier Information Letter, this one No. 675,

had been issued on February 8, 1985 and considered the impact of the amendments on products

that otherwise might have been considered as “Grandfathered”. It, too, was distributed to

“Manufacturers and Distributors of Medical Devices”:

1. Modified Implantable Devices

Concerns expressed about the delay in obtaining certain implantable devices

which have recently been modified and therefore become subject to Part V of the

Medical Devices Regulations. Implantable devices which were being sold prior to

April 1, 1983, do not need a Notice of Compliance, however, if the device is

²⁵⁶Exhibit 27 v. 3 at T. P

²⁵⁷Exhibit 30 at p. 7

Page: 76

modified, it becomes a “new device” as defined in Part V of the regulations. The

manufacturers must then submit test data and performance information for

evaluation; if the information is determined to be acceptable, a Notice of

Compliance will be issued to allow general sale.

Starting immediately a Notice of Compliance will be issued to allow the sale of a

modified device for a limited period if submitted information about the

modification is considered adequate to show that no adverse effects will result.

However, the manufacturer will be required, pursuant to Section 41 of the

Medical Devices Regulations, to make a full submission for the device as

indicated under Section 35 within one year from the date of such Notice of

Compliance. In the event that the submitted information is not satisfactory, the

Notice of Compliance may be cancelled under the authority of Section 40.²⁵⁸

[222] These modifications made with respect to the treatment of “grandfathered” devices and

the clarification of what would be understood to be a “dental implant” for the purposes of Part V

of the Medical Devices Regulations are both in furtherance of balancing the competing values of

bringing to market medical devices which would assist patients but doing so without a

disproportionate risk of harm. Even if this were not so, these changes would have no impact on

this case. Again, it was acknowledged by the Crown that the Vitek Proplast implants were not

subject to grandfathering and were to be treated as “new devices”. Temporomandibular joint

implants are attached to the vascular system and, accordingly, are implants requiring compliance

with Part V of the Medical Devices Regulations. They are orthopaedic and not dental implants.

[223] In 1984 the Environmental Health Directorate, at the time the responsible section of the

Health Protection Branch, published a “Guide to the Preparation of a Submission Pursuant to

Part V of the Medical Devices Regulations”. It sets the stage for such a submission:

It must be noted that there is no authority or mechanism under the Food and

Drugs Act to approve a medical device prior to its sale in Canada. It is the

responsibility of the manufacturer to ensure that the regulatory requirements are

met. Thus, for all devices except those listed in the Table to Part V, provided the

manufacturer can demonstrate on request that a device is safe, effective and

adequately labelled, he need only submit notification information as described in

Part II. For devices subject to Part V there are additional requirements. Certain

information and material must be submitted before sale to substantiate that the

new device has been adequately tested to demonstrate safety and high probability

of effectiveness in humans. If such information is adequate the Director (for this

purpose the Assistant Deputy Minister, Health Protection Branch) issues a Notice

of Compliance. If the evidence is unsatisfactory or inadequate, a Notice of

Compliance may be denied pending additional information requested. Sale of a

²⁵⁸Exhibit 34 v. II at T. 93

Page: 77

new device without receipt of a Notice of Compliance is a violation of the

Medical Devices Regulations.²⁵⁹

[224] Following its receipt, the March 17, 1987 submission seeking Notices of Compliance for

the Vitek Proplast products was passed to Nancy Shadeed for review. Although done under the

general direction of Nirmala Chopra within the auspices of what, at the time, was called the

Bureau of Radiation and Medical Devices, Nancy Shadeed was employed elsewhere in Health

and Welfare Canada. She was part of the Clinical Criteria section. During the latter half of 1986

and 1987 she worked doing premarket review. There was not enough work at the Clinical

Criteria Section. There was a backlog at premarket review.²⁶⁰Her role was to prescreen the

submissions to be sure they were complete.²⁶¹If accepted as complete, an application was then

reviewed as to sufficiency and adequacy. As was explained later by Dr. Richard Lawuyi, the

reviewers met once a week (“submission meeting”). The reviewer responsible for any particular

submission would present to the others and make a recommendation. There would be some

discussion and, Nirmala Chopra, as the responsible supervisor, would agree or not with the

recommendation that had been made.

[225] In this case, the submission received on March 17, 1987 was acknowledged by a letter

dated May 16, 1987 and signed by Nirmala Chopra as Head, Premarket Review, Division of

Clinical Assessment, Bureau of Radiation and Medical Devices. What was made plain by this

letter is the large number of applications included as part of this submission:

Thank you for your Submission received March 17, 1987 regarding Proplast I,

Proplast II, Proplast HA sent pursuant to Part V of the Medical Devices

Regulations.

Submission Numbers MSO17487 to MSO22187 have been assigned to these

devices…²⁶²

[226] Nancy Shadeed reviewed the submission and prepared a report. She determined that the

submission should be treated as incomplete. This conclusion arose from the large number of

devices for which an application was made and the difficulty in segregating the data applicable

to each of them:

This submission consists of many types of devices, whose purpose is to provide

an improved implantable composition of material which promotes ingrowth of

normal body tissue.

…

²⁵⁹Exhibit 48 at p. 3

²⁶⁰Evidence of Nancy Shadeed (May 23, 2019) at p. 11

²⁶¹Ibid at p. 11

²⁶²Exhibit 12 at T. 5 and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 41

Page: 78

Since the submission consists of many devices, the manufacturer should be

informed that separate applications should be made for each different indication

of use. A Master File can be used for Quality Assurance, plant description,

manufacturing process, microbiological safety and biocompatibility studies.²⁶³

[227] The foundation for this problem is underscored by the overview report prepared by

Christopher K. Ober which identifies differences in the various types of Proplast. Under the

heading: “The absence of common elements in the chemical and physical properties of the

various types and forms of Proplast^TM” it notes:

As a result of the differences in composition of the different Proplast^TMtypes and

forms and the strategies for combining Proplast^TMwith other materials, there are

many different kinds of “Proplast” with many different property sets. The

chemical and physical properties of the various types of Proplast^TMdepend upon:

a) The chemical composition including choice of filler.

b) The physical structure, porosity and the organization of the filler.

c) Details of the manufacturing process [no one knows what this is].

d) The nature of the substrate of which Proplast^TMis bonded.

e) The mechanical loading.

f) Duration implantation.

Polymers, including Proplast^TMare known to age differently, mechanically and

physically depending on the loads they are exposed to.

In order to determine the causes of failure of the various types, forms and designs

of devices manufactured from Proplast^TMit would be necessary to analyse each

one individually because of the variables listed above.²⁶⁴

[228] In her Reviewer’s Report, Nancy Shadeed concluded:

This submission should be rejected and the comments will reflect that a Master

File should be prepared on the sections that are common to all types of devices,

and a separate application for each different indication of use.²⁶⁵

[229] The report prepared by Nancy Shadeed was taken up and considered at a submission

meeting which took place on May 26, 1987. The minutes of that meeting note the issue, the

recommendation of Nancy Shadeed and the decision made:

²⁶³Ibid at T. 7 (Reviewer's Report, May 25, 1987) and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 40

²⁶⁴Exhibit 8 (Expert Report of Dr. Christopher K. Ober, August 24, 2018) at pp. 8-9

²⁶⁵Exhibit 12 at T. 7 and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 40

Page: 79

Proplast I, Proplast II, Proplast HA:

Submission consists of many types of devices whose purpose is to provide an

improved implantable composition of material which promotes ingrowth of

normal body tissue. As there are a number of different indications for use I feel

this should be divided into a Master File and a submission submitted for each

indication for use.

Recommend we reject with detailed letter explaining our requirements.

DECISION: Reject-send letter with detailed explanation of what is missing and

what should be included. Advise that a Master File would be a benefit.²⁶⁶

[230] The Reviewer’s Report completed by Nancy Shadeed noted that testing had been

undertaken and included the observation:

The devices are sold non-sterile but evidence that the device is sterile and safe are

not adequately presented. Biocompatability tests are a 2 year study done on

Beagle dogs. No physical testing is presented on the device. Clinical studies are

performed on a total of 499 cases, with a success rate of 97%. Packaging and

labelling are adequate.²⁶⁷

[231] Nirmala Chopra indicated in her evidence that she had concerns. She noted that Pierre

Blais was concerned with the use of Teflon but this was a general or generic concern. She had

advised Nancy Shadeed to speak to Pierre Blais but there was no record that this had ever taken

place. In her evidence Nancy Shadeed said this did not happen. Nirmala Chopra made no effort

to discuss this submission or the use of Teflon in Proplast with Pierre Blais at the time this

submission was being considered²⁶⁸

[232] Be that as it may, a Note to File made by Nancy Shadeed after the submission meeting of

May 26, 1987 makes clear these concerns were not the basis for the rejection. The submission

was found to be incomplete because the submissions for the various and different Proplast

products were lumped together. The information could not be disaggregated and associated

separately with each of the individual devices:

The reason for rejecting this submission is that it contains 40 types of devices. A

good description of how each works is not given. It is too confusing to have all of

these devices lumped together so that we are suggesting they prepare a Master

File and then submit separate applications for each indication of use²⁶⁹

²⁶⁶Exhibit 21 at p. 2

²⁶⁷Exhibit 12 at T. 7 and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 40

²⁶⁸Transcript of Nirmala Chopra (April 24, 2019) at pp. 71-72 and 101-102

²⁶⁹Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 36

Page: 80

[233] The decision was communicated to Vitek Inc. through a letter dated May 29, 1987, which

said, in part:

This is in regard to your submission numbers MSO17487 to MSO 22187 received

March 17, 1987 regarding Proplast I, Proplast II and Proplast HA. The

information submitted to establish safety and efficacy of the device as required by

Section 36 of the Medical Devices Regulations has been reviewed and is

considered to be incomplete.²⁷⁰

[234] As required by the decision which had been taken, a detailed explanation was included

with the letter. It said:

Please resubmit complete information as described in the guideline, with

particular attention to the following:

1. The submission presented consists of many devices that have different

indications for use. In order to facilitate the evaluation process, separate

applications should be made for each indication of use. A Master File can be

prepared for Sections 7 through 11 and 14 where company procedures,

components and materials are identical from one model to another. The

Master File may be referred to in subsequent submissions.

2. Performance characteristics should be specified for each device.

3. Engineering drawings should be provided for each type of device.

4. Devices which are supplied non-sterile should include all information related

to the recommended sterilization procedure that results in a sterile pyrogen-

free device.

4. [sic] Physical testing for each type of device, should include test procedures

and criteria of acceptability for all tests.²⁷¹

[235] Subsequently, by letter dated July 13, 1987, the submissions that had been made were

returned to Vitek Inc.²⁷²

[236] A second submission was made in 1988. In the interim Vitek Inc. sought advice and

assistance from the premarket section of Health and Welfare Canada. In preparing to resubmit,

on March 1, 1988, Gene L. Fagelson, Quality Assurance Manager, Vitek Inc. spoke on the

telephone with Marc-Andre Cote, an evaluator with the premarket section of Health and Welfare

Canada, who made a note to file:

²⁷⁰Exhibit 12 at T. 8 and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 34

²⁷¹Exhibit 12 at T. 8 and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 35

²⁷²Ibid at T. 9 and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 21

Page: 81

Upon discussion with Mr. Fagelson [phone number included] on March 1, 1988,

it was agreed that, due to the complexity of the file and to past rejection of the

submission, a visit to Ottawa would be the best course of action. He will arrange

an appointment with Mrs. Chopra and present his submissions in person.²⁷³

[237] The proposed meeting took place on March 15, 1988. A follow-up letter was written by

Gene L. Fagelson to Nirmala Chopra. It was delivered with samples of the packaging to be used

and of the product with more material to be provided. The letter suggests that the company

understood the problem that was the basis of the earlier rejection:

This letter is a follow-up on our conversation of 15 March. At that time, I

promised to have to you the revised submission which breaks our total product

mix into like groupings.²⁷⁴

[238] The second submission (or resubmission) was received by Health and Welfare Canada on

April 26, 1988.²⁷⁵Nirmala Chopra assigned responsibility for the review of this submission to

Dr. Richard Lawuyi. She left shortly thereafter and was not part of the review or consideration of

these applications. Richard Lawuyi is not a medical doctor. He has a PhD. in organic chemistry

from Carleton University. After receiving his PhD. he spent one year in a post-doctoral program

at Agriculture Canada. From there he became a research scientist at Forintek Canada, an agency

funded by the federal government looking to improve “forestry products” by adding polymer

resin particles and increasing durability by soaking the wood in polymers. In 1986 he took a

position with the University of Manitoba as a research associate. He held other positions but in

1988 joined the Medical Devices Bureau.

[239] Richard Lawuyi had not been there very long when the 1988 submission made by Vitek

Inc. was given to him for review. He recalled that the workload was heavy and that when he

arrived there was a significant backlog. Richard Lawuyi was asked if he was familiar with a

memorandum, dated March 8, 1988, prepared by W.J. Welsh, the Acting Chief, Pre-Market

Division, Bureau of Radiation and Medical Devices. He did not recall seeing it at the time but

did recollect it being discussed at a meeting that he attended. The “Welsh Memo” was the

subject of discussion through the course of the trial. It was a response to the backlog and delay in

processing applications for Notices of Compliance:

Pre-Market Review

In an attempt to speed-up the pre-market review process, the following

modifications are being implemented. Submissions for “simple” devices (e.g.

Non-electronic drug delivery systems) will be assessed to determine reasonable

assurance of safety (toxicity, biocompatibility, sterility, etc.). Efficacy and clinical

aspects will not be assessed in detail. Malfunction of this type of device should

²⁷³Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 16

²⁷⁴Ibid at p. 3

²⁷⁵Exhibit 16 (1988 Vitek Proplast Submission Dockets) at p.1

Page: 82

not precipitate a life-threatening situation since the device itself is not therapeutic.

Problems would more likely be user rather than device related.

Minor deficiencies will not result in the notice of compliance being delayed.

Rather such requests for additional information will be made in the letter which

accompanies the notice of compliance, and will be for the purpose of “completing

our files”. Should a manufacturer not co-operate within a reasonable period of

time, we will have to be more insistent with the next submission received from

him.²⁷⁶

[240] This document was the source of some debate. Could it be an indication of a systemic

effort to speed up the process at the cost of a proper and complete review? Should it be taken as

implying a willingness to obfuscate and a failure to properly consider the acceptability of the

testing done to demonstrate the safety and efficacy of medical devices for which Notices of

Compliance were being sought? The point was made, and I accept, that while this was an effort

to contribute to the expediting of the review of certain applications it had no effect in respect of

Vitek Proplast Implants. The memorandum is conditioned. It is to apply only to “simple

devices”. It was accepted by all parties that the Vitek Proplast products could not be categorized

as “simple devices”. There is nothing in the evidence that suggests that this memorandum was, in

any way, brought to bear on the consideration of whether Notices of Compliance should be

issued in respect of any of these “devices”.

[241] It was about this time that another of the documents which originated with Pierre Blais,

and where the authenticity was questioned by the Crown, could have come into play. Pierre Blais

said that on April 28, 1987 he gave a paper entitled “Frangible, Degradable and Dispersible

Implant Materials” to a group of medical professionals at a “Critical Care ‘87” conference at a

convention centre in Hamilton, Ontario. To my reading, this is a document which contains

general statements without data or proof. The opening paragraph makes the point:

Detailed long term studies often reveal widely used implant variables that lack

stability. Many such substances have remained in commerce because they fulfil a

need and adverse reactions are tolerated. With the passage of time and with

increasing usage, bothersome complications become expectations and no longer

attract attention. These substances are now being encountered in new forms and

novel products which placed greater demands on the constituents. Changes in

physical properties are more noticeable and less tolerable. Degradation products

appear sooner and in greater quantities. Leachables and metabolites often have

pharmacologic effects complicating the management of conditions for which the

implant was prescribed in the first place.²⁷⁷

[242] This begs many questions: What studies? Which widely used implants? What substances

remain in commerce to fill a need? What new forms and novel products? And so on. The paper

²⁷⁶Exhibit 12 at T. 31, Exhibit 56 at T. 6

²⁷⁷Exhibit 34 v. 1, T. 81 and Exhibit 73 T. 6

Page: 83

does refer to Proplast as “a controversial material found in many implant systems” and as a

composite product that has “been of concern since the 1970’s”.²⁷⁸

[243] The Crown says the document should not be relied on. Before a scientist employed by the

Crown publishes or speaks to a paper, it must be approved by senior management.²⁷⁹There is a

form to be completed and signed. There was, in the record, such a form which purported to be

the requisite approval for this paper. But is it? The paper and the form were produced by counsel

for the Plaintiff to Justice Firestone as an enclosure to an email delivered at 1:05 AM on Friday,

October 26, 2018, in preparation for a pretrial that was to be held later that day and to counsel for

the Crown “…as quickly as I could after receiving it at midnight”.²⁸⁰

[244] The Crown, in reviewing its files, found an approval form for another paper, this one

entitled; “Future of Lasers in Critical Care”.²⁸¹Both this one and the form said to be the approval

for the paper “Frangible, Degradable and Dispersible Implant Materials” were given to the

forensic document experts to review. The problem is that when one of the approval forms is

transferred to a plastic film and laid over the other, the bottom halves, the part of the page with

the signatures and dates written into the form as well as other handwriting, printing and

extraneous markings, match exactly. It was apparent that one was copied from the other.

[245] Since only one of them has been found in the historic files of the Crown a reasonable

inference is that it is the other one, the one produced by Pierre Blais late in the lead up to the trial

(“Frangible, Degradable and Dispersible Implant Materials”), that is a copy.

[246] There is in the Record an “incomplete bibliography” of “articles, reports, and other

similar projects” attributed to Pierre Blais and attached as an exhibit to an Affidavit sworn by

him in this action, on June 6, 2018.²⁸²The bibliography refers to the paper “Future of Lasers in

Critical Care” as having been a Keynote Lecture at the Critical Care ’87 symposium in Hamilton

on April 28, 1987. It appears that the same paper was given at a similar symposium in Toronto at

some other time during 1987. The bibliography also lists the paper “Frangible, Degradable and

Dispersible Implant Materials” as having been given in Hamilton in the “Proceedings of Critical

Care ‘87” on April 27-28, 1987. However, the program for that conference makes no reference to

it.²⁸³Although counsel advised Justice Firestone that this paper was also given in similar lectures

during 1987 in Toronto and Edmonton the bibliography makes no reference to those

presentations. The email delivering the paper to Justice Firestone indicated that the paper was

“published in the Proceedings of a Symposium on Emergency and Critical Care organized by the

Hamilton Hospitals in 1987”²⁸⁴but those proceeding are not, so far as I am aware, included in

the record of this trial. Similarly, there is a “Project Area Review” for the premarket program

that was co-ordinated by Nirmala Chopra. It is dated January 18, 1988 and under heading “G.

²⁷⁸Ibid at pp. 6 and 10

²⁷⁹Affidavit of Pierre Blais sworn June 6, 2018 at para. 6

²⁸⁰Exhibit 34 v. 1 T. 81

²⁸¹Exhibit 73 T. 7

²⁸²Affidavit of Pierre Blais, sworn June 6, 2018 at Exhibit 2

²⁸³Exhibit 79 (Forensic Laboratory Report, June 17, 2019) at T. A (Proceedings Book).

²⁸⁴Exhibit 34 v. 1 T. 81

Page: 84

1987-88 Reports” lists among other things “Journal publications”, “proceedings”, “papers” and

“lectures”. The list includes, by reference to April 28, 1987, the paper “Future of Lasers in

Critical Care” but makes no reference to the paper, “Frangible, Degradable and Dispersible

Implant Materials”.

[247] On the balance of probabilities, for the purposes of this trial and from the record

produced here, I find that the approval form for the paper “Frangible, Degradable and

Dispersible Implant Materials” was constructed by copying what was a proper approval of the

paper “Future of Lasers in Critical Care.”

[248] I wish to be clear about the appropriate implications to be taken from this finding.

[249] There is, I suppose, the possibility of a benign explanation for the falsifying of the

approval form. None was offered. More importantly, I am not prepared out-of-hand and based

solely on this determination to ignore or take as false all the evidence provided by Pierre Blais.

He was a long-time employee of Health and Welfare Canada and, despite some difficulty,

particularly around his departure was, his employment reviews suggest, a valued one. What is

appropriate is to weigh his evidence carefully against what others have said where that evidence

appears to be probative and helpful to the Court in deciding the issues.

[250] By way of example, on being shown that the paper “Frangible, Degradable and

Dispersible Implant Materials” was not referred to in the program of the Critical Care ’87

symposium, Pierre Blais said, for the first time, this was not a paper but a “workshop”. It was

suggested there was another list that would show it. None was forthcoming. When it was pointed

out to Pierre Blais that the “Project Area Review” made no reference to the that paper, Pierre

Blais suggested he had not reviewed the document. If he had, he would have caught the

omission. I do not accept either of these explanations. There is nothing that confirms these out-

of-hand attempts at clarification.

[251] In any case, the paper “Frangible, Degradable and Dispersible Implant Materials” is of

little assistance. The email sent by counsel for the Plaintiff to the attention of Mr. Justice

Firestone suggests the failure to produce this paper as an indication of serious failures by the

Crown and as indicative of knowledge that required the Crown to act. Its failure to do so is taken

as a confirmation of its negligence. The email says:

This Paper demonstrates that:

1. HC gave public presentations about hazardous products like Proplast;

2. HC was fully aware of the injury potential and problems the products posed;

3. HC routinely released gave technical information [sic] to hospitals about

hazards and protection of Patient Safety on request by Hospitals, including the

presentation of clinical rounds and lectures;

4. HC’s Executive Officers reviewed, edited and gave formal authorization for

teaching seminars and public symposia on these and related issues; and

Page: 85

5. The Attached EHCX Approval Document evidenced Executive actual,

detailed and specific knowledge of specific Hazards from these papers.²⁸⁵

[252] The paper does none of these things. As it is, there is doubt as to whether it was presented

and whether it was approved. In the absence of approval there is nothing to say that it came to

the attention of senior management at Health and Welfare Canada but, in any event, general

statements that a product is “controversial” and “been of concern since the 1970’s” even said in

the midst of a paper expressing a broader concern about the tendency of an array of products to

degrade is not enough to support the listed inferences or to require regulators to act in some

specific way. It could be said that, from the perspective of the Plaintiff, appropriate action was

taken. As will become apparent and, as already noted, the applications for Notices of

Compliance were, for the most part, refused. In this case the paper, if delivered, was to a small

group of professionals. There is no demonstration that it was broadly distributed.

[253] I return to Richard Lawuyi and his review of the 1988 submissions made in support of the

applications for Notices of Compliance in respect of the Vitek Proplast products. In this case,

unlike the submission made in 1987 the application was treated as complete and a review of the

substance undertaken. This is not to say that the problem identified by Nancy Shadeed did not

continue. The submission was comprised of 20 binders seeking Notices of Compliance for 51

Vitek Proplast devices. Proplast taken on its own is not a device; it is a material. Thus, the need

for separate applications for each of the 51 devices. Consistent with the concern raised in respect

of the 1987 application there was, in 1988, a Master File. The expectation of Nancy Shadeed was

that such a file would deal with the issues common to all the applications, leaving the device-

specific issues to separate binders dealing the separate applications. Of the 20 volumes there are

two more that are of immediate interest: one deals with “TM Joint Implants”²⁸⁶and the other

with “Block and Sheeting”.²⁸⁷

[254] The Master File did not satisfy the purpose set for it. The principal concern in any

application is, on the one hand, the safety of the device being considered and, on the other hand,

its efficacy. A large measure of the information directed to these questions originates with testing

where animals are the subjects, and clinical testing on humans. This is something that would

require consideration directed to each device. At a minimum it would be plain what was being

relied on to demonstrate the safety and efficacy of each of the devices that were the subject of a

request for the issuance of a Notice of Compliance. That was not the case with this submission.

The Master File is where the testing is reported. This is done by reliance on the tests done on

beagle dogs and reported in 1975. The submission summarizes the test as follows:

Both porous and non-porous forms of Proplast were tested in, Beagle dogs for two

years. Cylindrical porous Proplast’s and flat plated non-porous Proplast were

implemented in the femurs of separate groups of dogs. A group in which U.S.P.

Plastic Standard coupons were implanted and a sham control group were run

²⁸⁵Ibid

²⁸⁶Exhibit 15 v. 1 at pp. 227-359

²⁸⁷Ibid at pp. 360-444

Page: 86

concurrently. Each group consisted of eight beagle dogs, four male and four

female equalized to mean the group weights.

No findings of toxicological significance were evident in this general observation,

ophthalmology, bodyweight, hematology and clinical chemistry data, or in the

necropsy and histopathological examinations. …²⁸⁸

[255] It does not take much to see that this does not assist in understanding the variable impacts

that could occur in hip, knee, ophthalmology, facial reconstruction or temporomandibular joint

applications. The remaining parts of this segment of the Master File, the only place the test

results are reported, contain a bibliography which groups the work into:

(1) “Oral and Maxillofacial Surgery” which included “maxillary retrusion” described

as a “dento- facial deformity”, “protracted mandibular dislocation”,

“osteotomies”, “chin implants”, “meniscus replacement”, “ankylosis”, “severe

malocclusion and bird-face appearance”, “three wall osseous defects” and other

issues;²⁸⁹

(2) “Plastic and Reconstructive Surgery” which included “Effects of Stress on

Healing Wounds” “Soft Tissue Response to Blood Impregnated Proplast”

“Proplast Reconstruction of the Lower Sternum” “Clinical Experiences with

Proplast As Implant” “Proplast, a Porous Implant for Contour Restoration”,

“Synthetic Materials in Orbital and Surrounding Tissue” as well as other papers²⁹⁰

(3) “Orthopedic and Hand Surgery” which included the use of a

polytetrafluoroethylene/vitreous carbon porous material used as an alternative to

acrylic for hip endoprosthesis fixation, a study comparing acrylic cement, Proplast

and porous coated Co-Cr-Mo in a loadbearing canine tibia model; a study of a

prosthesis coating material used in clinical and experimental surgery including

femoral head prostheses, cruciate ligament appliances, augmenting devices of the

alveolar ridge, zygomatic process and mental bone, heart valve stabilization and

tracheal prostheses; a study examining implant stabilization in terms of the

interaction between the surface of an implant and adjacent tissue as governed by

four postulated key parameters; the examination of the proplast prosthetic stent as

used as a replacement for the cruciate ligament of the knee; a study looking at the

use of forty-five stemless Proplast-covered silicone rubber trapezium implants in

respect of forty patients after trapeziectomy for either osteoarthritis, rheumatoid

arthritis or trauma;²⁹¹

²⁸⁸Ibid at p. 14

²⁸⁹Ibid at pp. 24-34

²⁹⁰Ibid at pp. 34-38

²⁹¹Ibid at pp. 38-51

Page: 87

(4) “Gynecology” which included a preliminary study of “oviduct occlusion” and the

prevention of adhesions in baboons and “oviduct occlusions” following the

implantation of Proplast;²⁹²

(5) “Oto-Rhino-Laryngology” which included the use of Proplast in a series of

osteoplastic frontal sinus operations using the osteoplastic flap technique and the

implanting of this synthetic material; the use of a total alloplastic ear prosthesis

consisting of Teflon and pyrolytic graphite in three patients; an evaluation of

Proplast as a new alloplastic material for use in head and neck reconstructive

surgery; an evaluation of Proplast as a self-stabilizing alloplastic material in ear

surgery (33 patients) and in facial reconstructive surgery (11 patients); the

removal at revision surgery of 16 Proplast and 52 Plastipore prostheses examined

histologically and the findings illustrated;²⁹³

(6) “Ophthamology” which included testing in rabbits of Proplast for corneal

tolerance and acceptance; two cases of late reconstruction of the orbit in which

there had been moderate disruption of orbital anatomy; visual rehabilitation in

otherwise blind individuals through use of the Girard keratoprosthesis; the use of

hemi-spherical implants of Proplast 15 mm. in diameter that had been fashioned

similar to Castroviejo’s implants; the testing of Proplast as primary spherical

implant after unilateral enucleation in albino rabbits;²⁹⁴and

(7) “General Interest” which included an “experiment” intended to evaluate the

tensile strength of PTFEC after aging in two solutions at different temperatures; a

study of femoral stems of Thompson prostheses coated with Proplast using

conventional histological examination, scanning electron microscopy and electron

probe microanalysis in “successful” firm implants and in “loose” clinically

unsuccessful implants; the description a rapid in vitro screening protocol to guide

selection and monitoring of polymers for implant or extracorporeal applications; a

poste presentation of the “porosity determination” of “a low modulus implant

material” (presumably proplast).²⁹⁵

[256] The breadth of these areas and the variable subject matter of these studies makes clear the

difficulty in associating a particular medical device for which a Notice of Compliance was being

sought with the tests and work that would support its safety and efficacy.

[257] This section of the Master File also presents pages summarizing the number of

“craniofacial augmentation” surgeries carried out at a variety of different locations²⁹⁶as well as

one page providing a similar summary (only numerical, no analysis) of otoplasties carried out²⁹⁷

²⁹²Ibid at p. 51

²⁹³Ibid at pp. 51-60

²⁹⁴Ibid at pp. 60-62

²⁹⁵Ibid at pp. 62-64

²⁹⁶Ibid at pp. 82-95

²⁹⁷Ibid at p. 96

Page: 88

and another one page numerical summary of “PROPLAST IMPLANT MATERIAL, Causes of

Failure, All Followed Cases (1970-December 1977)”.²⁹⁸This is followed by another 128 pages

of material. The purpose of it is hard to discern. There is an index to the Master File but no pages

dividing the topics these subsequent pages were to deal with. What is clear is that there is

nothing that would allow for an appreciation of anything being specifically directed to any one or

group of the 51 devices being considered for Notices of Compliance. Presumably they were to be

applied to all of those devices underscoring that the objection of Nancy Shadeed to the earlier

1987 submission remained.

[258] This concern was manifest in the response of Richard Lawuyi to the second (the 1988)

submission. The issue was recalled at a submission meeting held on June 21, 1988:

Initial submission was made in May 1983 and rejected in 1987 due to lack of

efficacy data and large number of devices all lumped together…²⁹⁹

[259] There was a further submission meeting on June 27, 1988. The Minutes of the meeting

note the range of applications:

There are 51 devices and 20 binders altogether. Proplast is an implant material

used in facial and cosmetic surgery and for diverse bone irregularities. They are

made in all shapes and sizes ranging from the angular zygomatic arches to quarter

moon -shaped chin augmentation. They can also be trimmed by the surgeon to fit

individual needs (blocks, sheets, laminated, non-laminated, porous to non porous).

All used in augmentation of facial bony contours.

[260] The presence of a significant literature and the claims made based on that literature was

referred to:

There are extensive literature reports and publications some dating back to 1976

all giving favourable commendation to Proplast. They all claimed it is efficient

and safe. For example out of 499 craniofacial and otological procedures there are

13 failures resulting from: 5 chin infections, 2 chin postoperative trauma, 1 nasal

post operative trauma, 1 zygomatic infection, 4 extrusion followed by

replacement.

[261] This is followed by the expression of concern for the lack of detail and appropriate

testing:

General comments on Quality Assurance, no numbers, figures, charts or

indications of audits.

General comments on testing methods, no details or numbers. Reflux destructive

test, lateral pull tests.

²⁹⁸Ibid at p. 97

²⁹⁹Exhibit 56 T.8 (Minutes of Submission Meeting, June 21, 1988)

Page: 89

[262] And a decision made asking for the purpose of each of the devices and raising questions

as to the efficacy of some of them:

Decision check the intended use for each. If for ligament reconstruction determine

the efficacy of the device.³⁰⁰

[263] Two days later on June 29, 1988, Richard Lawuyi spoke to Gene Fagelson who had

telephoned inquiring as to the status of the 1988 submission. Richard Lawuyi advised Gene

Fagelson that the Medical Devices Bureau was not happy with how the submission had been

organized and that the Medical Devices Bureau would be requesting additional data to support

the safety and efficacy of Vitek Inc.’s orthopaedic devices. Gene Fagelson advised that Vitek

Inc. had not received approval from the United States Food and Drug Administration for

Proplast-based orthopaedic implants.³⁰¹Richard Lawuyi described orthopaedic devices as those

intended for use in the skeletal system, which were distinct from other types of devices in the

1988 submission, such as facial implants, which were indicated for use in soft tissue. Richard

Lawuyi identified Vitek Inc.’s temporomandibular joint implants as orthopaedic devices.³⁰²

[264] There was another submission meeting on July 5, 1988. The concern for efficacy was

repeated in respect of the broader category of orthopaedic uses (as I understand it ligament repair

is a subset of orthopaedic surgery) and for those uses the concern for better information

substantiated:

On the basis of my conversation with Mr. Fagelson and the FDA, it appears that

the orthopedic devices have not been allowed on the market in North America

because evidence of the safety and efficacy of these devices is lacking. I am

therefore recommending an F. I. [Further Information] for the orthopedic

ones…³⁰³

[265] On July 26, 1988 the issue arose at a further submission meeting. As the Minutes report:

Mr. Gene Fagelson called. He wanted to know what more is required for safety

and efficacy as in our FI letter. I [Richard Lawuyi] told him results from the

literature submitted are not adequate.³⁰⁴

[266] A decision was taken to refer that issue to the “Clinical Advisory Division”. On August

16, 1988, the Clinical Advisory Division reported back. It confirmed the problem but it also

shows that the Clinical Advisory Division had done some of the work that was expected from

Vitek Inc, as the applicant for the Notices of Compliance. The Clinical Advisory Division had

³⁰⁰Exhibit 17 (Minutes of Submission Meeting, June 27, 1988), Exhibit 56 T. 9

³⁰¹Transcript of Richard Lawuyi (May 28, 2019) at pp. 30-31; Exhibit 16 at p. 97; Agreed Statement of Facts at

para. 106

³⁰²Ibid at p. 31

³⁰³Exhibit 47 T. 2 (Minutes of Submission Meeting, July 5, 1988)

³⁰⁴Ibid at T. 3 (Minutes of Submission Meeting, July 28, 1988

Page: 90

separated out and grouped the 32 various devices for which information supporting efficacy was

required:

There are 8 types of Proplast T.M joint devices in this submission. The

manufacturer has collected a large number of journal articles and other

publications on clinical experience with these devices. Some of these articles may

be useful to demonstrate the safety and effectiveness of Vitek devices. However,

the manufacturer will first have to choose which articles they wish to associate

with each type of device. The clinical data presented must be generated by the use

of the Vitek Devices, or the manufacturer must make the claim that their device is

identical to the devices described in the publications. The present format of this

submission is not useful for the demonstration of safety and effectiveness of the

devices for which the notice of compliance is being requested. A copy of our

Guide for reporting of clinical trial data could be sent to the manufacturer.³⁰⁵

[267] This was followed by another submission meeting, this one on August 22, 1988, which

considered the comments received from the Clinical Criteria Division:

Proplast T.M.J. (Temporo Mandibular Joint) Implant

Comments have now been received from the Clinical Criteria Division. There are

8 types of TMJ implants.

1. Vitek has been asked to sort out the literature reports and publications into

groups and then associate each group with the corresponding group of

devices.

2. It will be necessary to clarify specifically which device(s) was used in the

above publication(s).

Recommend: a FI [Further Information] to this effect.

Decision: send letter to request clarifications as recommended by Dr. K .

Magwood³⁰⁶

[268] The results and the conclusion of the premarket review section were communicated to

Vitek, Inc. by a letter dated September 2, 1988. It makes clear that the concern with respect to

efforts of the company to demonstrate safety and efficacy, now narrowed to the various forms of

temporomandibular joint implants, remained:

Dear Mr. Fagelson:

³⁰⁵Exhibit 16 p. 86 (Letter from K. Magwood to WJ. Welsh, August 16, 1988)

³⁰⁶Exhibit 56 T. 13 at p. 4

Page: 91

This is further to my letter of July 7, 1988, and the telephone conversation

(Lawuyi and Fagelson) regarding the Proplast T.M. Joint Implant (submission

numbered MSO39288 to MSO40188).

Your submission has again been carefully evaluated in order to establish safety

and efficacy for the subject device the following is required:

- Because there are really eight different types of devices in this submission,

the literature articles and publications on clinical experience will have to

be broken down into eight different groups. Each group will then have to

be associated with the corresponding device and the model designation as

well. (A sample copy of our breakdown is attached).

- identification of the articles and publication on clinical experience that

directly refer to Vitek products.

If you have any further questions please contact this office.³⁰⁷

[269] The applications for Vitek Poplast TMJ implants were refused.

[270] The Submissions of the Plaintiff identify substantive concerns with the review of these

submissions:



the insufficiency of any physical testing on “the device”

concerns with the “beagle studies”

the methodology of the surgeries and whether they contribute to an understanding

of the applicable safety and efficacy.

[271] As the Submissions of the Plaintiff note, Richard Lawuyi dealt with each of them:



He did not agree there had been no physical testing (“I saw some physical

testing….”) and went on to say: “...but it does not affect anything because I did

not [review] it in detail. We asked Mr. Fagelson to reorganize it so we can

examine all the details, all the experimental details, both physical and biological

tests”.³⁰⁸



With respect to the beagle studies he noted: “They did indicate that it was to

replace the femur. It was for biocompatibility aspect [sic]. Even in that, you

cannot infer anything about the bio functionality which is even more important in

³⁰⁷Exhibit 16 p. 81 (Letter L. Boulay to Gene L. Fagelson, September 2, 1988), Exhibit 56 T. 14 and Exhibit 58 T. 2

³⁰⁸Transcript of Richard Lawuyi (May 28, 2019) at p. 70

Page: 92

this case.”³⁰⁹Richard Lawuyi added: “…usually in studies like this when we

don’t understand, we have to ask them to explain how it was done.”³¹⁰



As for the surgical methodology Richard Lawuyi said: “It doesn’t help in the

evaluation. It may be for the doctors who are doing the implant, doing the surgical

procedures” but that document has nothing to do with safety or efficacy

evaluations. “There’s lots of stuff to read that we don’t think have any impact on

the evaluation and the results, but still, there are somewhere that we looked at.” ³¹¹

[272] What these comments and the response confirm is the overarching concern for the lack of

proper organization of the material that made up the submission. It was impossible to assess

them properly because it was unclear how the information was to be applied and to which of the

devices any particular piece of that evidence was relevant. This was the principal concern raised

by Nancy Shadeed in her earlier evaluation albeit one that dealt only with the completeness of

the submissions.

[273] Following his June 29, 1988 telephone conversation with Gene L. Fagelson, Richard

Lawuyi prepared a note to file:

Mr. Fagelson called. Inquired about the status of his submission. I told him that

you would be hearing from us within a month. I also informed him that we would

be requiring more data to support safety and efficacy of the orthopedic devices.

To this he replied that he is no longer interested in the orthopedic ones because

the company has not sold any in North America and they could not get approval

from FDA anyway.³¹²

[274] There were applications for Notices of Compliance for devices other than the 32

identified as TMJ implants. Among those accounted for in this way were the applications for

“Block and Sheeting”. As understood by Richard Lawuyi these applications were for uses other

than as temporomandibular joint implants. They were for facial implants only.

[275] The day following his telephone conversation with Gene Fagelson (June 30, 1988)

Richard Lawuyi called Dr. Carl A. Larson of the FDA. In his evidence at trial, Richard Lawuyi

outlined the substance of this call:

The subject was the TMJ from Vitek. He was telling me, he was informing me

that approval had not been given to the orthopedic Proplast devices but

permission has been given to market the facial implants only. He realized that

³⁰⁹Transcript of Richard Lawuyi (May 29, 2019) at p. 39

³¹⁰Ibid at p. 40

³¹¹Transcript of Richard Lawuyi (May 27, 2019) at p. 113

³¹²Exhibit 16 at p. 81 (Note to File)

Page: 93

they were having problems with the TMJ or the orthopedic devices. That was one

of our main evidences that we should not give any approval.³¹³

[276] It was after the call to Dr. Carl A. Larson that the submission meeting of July 5, 1988

took place. Following the recommendation that Further Information be requested for orthopaedic

devices, the Minutes of that meeting go on to indicate that a Notice of Compliance will be

recommended “for facial implants only”. This is followed by the decision taken at the meeting:

Decision: Issue Notice of Compliance facial implants and get letter from

manufacturer to the effect that the devices will not be indicated for ligament

repair.³¹⁴

[277] It seems that the letter confirming the advice that Vitek Inc was no longer interested in

obtaining Notices of Compliance for orthopaedic uses was not sought or provided. Certainly,

Richard Lawuyi did not know if such a letter was sent.

[278] He did not write one.³¹⁵Instead, on July 7, 1988 W. J. Welsh A/Chief, Premarket

Division sent a letter to Gene L. Fagelson Quality Assurance, Vitek Inc.:

Dear Mr. Fagelson:

This is in reference to your submissions numbered MSO37188 to MSO42288

received April 26, 1988, concerning Proplast’s I, II and HA submitted pursuant to

Part V of the Medical Device Regulations.

Your submissions have been carefully reviewed and the following devices

recommended for issuance of Notices of Compliance. The relevant documents

will be forwarded under separate cover.

Preform Facial Implants MSO37688 to MSO38788

Facial Blocks and Sheeting to MSO41588

However, current data including clinical studies, clearly demonstrating safety and

efficacy will be required for the following devices:

Anaform Hip Prostheses

TM Joint Implants

Total and Partial Ossicular Replacement Prostheses

³¹³Transcript of Richard Lawuyi (May 28, 2019) at p. 39

³¹⁴Exhibit 47 at T. 2 (Minutes of Submission Meeting, July 5, 1988)

³¹⁵Transcript of Richard Lawuyi (May 29, 2019) at p. 55

Page: 94

Tissue Cushion Pad

Trochanter Pad

Staple Cushion Pad

Trapezium Implants

Please find enclosed a copy of the Medical Devices Regulations and Guide to aid

in preparing the required information.³¹⁶

[279] On July 11, 1988, as enclosures with a covering letter, Notices of Compliance were

delivered. The letter made clear the limits understood, by Health and Welfare Canada to apply.

The opening paragraph stating:

Dear Mr. Fagelson:

This is a reference to your submissions, numbered MSO37688 to MSO38788 and

MSO40288 to MSO41588, of April 25, 1980, received April 26, 1988, concerning

the Preform Facial Implant and the Facial Blocks and Sheeting submitted

pursuant to Part V of the Medical Devices Regulations. The information supplied

has been reviewed and is considered adequate to issue the notices of

compliance.³¹⁷

[280] As described in this letter, the devices subject to the Notice of Compliance that was

enclosed, were associated with “facial” work. Consistent with this understanding,

correspondence from Health and Welfare Canada refers to the grouping as “Facial Block and

Sheeting”. This can be read as attaching the adjective “facial” to both “Block” and “Sheeting”.

On a preliminary look one might wonder if this was accurate. For the devices labelled as

“Block”, that word is preceded by the word “facial” where the product is identified as “Sheeting”

the modifier “facial” does not appear in this correspondence.³¹⁸The “Purpose” for these devices

be they “Block” or “Sheeting” is described in the Submission supporting the request for issuance

of Notices of Compliance as:

Proplast Block and Sheeting Implant material are intended for augmentation of

either hard or soft tissue and bony contours where congenital or acquired

deficiencies exist. The highly porous nature of the material allows for stabilization

of the implant by tissue ingrowth.³¹⁹

[281] Read on its own this perceives the use of this material for more than just facial

applications. The adjective “facial” does not appear. However, what follows suggests otherwise.

³¹⁶Exhibit 16 p. 93

³¹⁷Exhibit 16 p. 88, Exhibit 12 T. 32 p. 13 and Exhibit 56 T. 18 (after the green sheet)

³¹⁸Exhibit 15 (Vitek Proplast Submission 1988) v. 1 at pp. 363-365

³¹⁹Ibid at p. 366

Page: 95

On the pages of the Submission, that come after this statement of purpose, are sheets dealing

with some or all of the applicable devices, some identified as “Sheeting”, others as “Block” and

one as a “zygomatic implant”³²⁰. Each one has a heading “Indication” which stands as an

indication of the use to which the particular device(s) might be put. All but one are indicated for

a use related to the “augmentation of facial bony contour” [Emphasis added]. The exception is

“PROPLAST I ULTRA – THIN SHEETING” which is “especially indicated for microsurgery

applications (such as middle ear surgery) where delicate bone and certain cartilage reconstruction

is required…”³²¹When the more general statement of purpose is read in conjunction with these

more specific indications of the use to which these devices could be put it becomes clear that

both “Block” and “Sheeting”, as the subject of Notices of Compliance, were only to be

associated with “facial” uses. There was no suggestion that these Notices of Compliance

contemplated the use of Block and Sheeting for orthopaedic uses. This understanding

underscores the significance of the acknowledgment apparently expressed by Gene L. Fagelson

that Vitek Inc. was no longer interested in approval of orthopaedic implants and the advice that

the Food and Drug Administration had not approved Proplast for such purposes.

[282] The materials that make up the Submission include what were referred to as “product

monographs”. These are documents which describe the product, uses and protocols that govern

the use of the devices to which it applies. The monograph is to be included with each product

item sold to advise the user, presumably the physician and surgeon, as to the nature, prospective

uses and limitations of the device. At that point they will stand apart from the rest of the

Submission. Once it is understood that a Notice of Compliance is not an approval, just an

authorization to enter the market, it becomes apparent that these documents do not legislate use

but provide guidance as to how the device might assist patients and how to make use of it. The

monograph is a guideline, it is not legislation or regulation.

[283] In this case no monograph was provided for each of the devices that fell within the

grouping of “Facial Block and Sheeting”. Put differently, the product monograph does not deal

with the individual devices for which Notices of Compliance were sought and granted. There

was one general document evidently intended to be used for all of them. It begins with a caution:

CAUTION: INDIVIDUALS USING THE IMPLANTS DESCRIBED HEREIN

MUST HAVE PROPER TRAINING AND EXPERIENCE FOR SUCCESSFUL

PROCEDURAL RESULTS. PROCEDURAL SUCCESS IS SIGNIFICANTLY

TECHNIQUE DEPENDENT. ³²²

[284] This makes clear that those who used these devices needed to have experience to

understand and make judgments about the use of the product. The “General Description” begins

by repeating the statement of purpose albeit with reference only to Block and not to Sheeting

and, as before without the apparent limitation of the word “facial”:

³²⁰Ibid: sheeting at pp. 368, 370, 372, 374, 382, 386, 388, 390, 392, 394, 396; facial block at pp. 380, 384, 398 and

zygomatic implant at p. 376

³²¹Ibid at p. 386

³²²Ibid at p. 417

Page: 96

General Description

Ultra porous Proplast^RI (gray) II (white) and Proplast-HA^TM(Hydroxylapatite)

(white) in block form are intended for augmentation for either hard or soft tissue

and bony contours where congenital or acquired deficiencies exist the highly

porous nature of Proplast implant materials can permit stabilization of the

impact by tissue ingrowth.

[285] What comes thereafter concerns the three versions of Proplast which are used as a

material in the manufacture of the devices being the various forms of Block and Sheeting that

were issued Notices of Compliance. Here, there is a reference to the use of this material having

been used in “temporomandibular and orthopaedic endoprostheses” as a coating:

All types of Proplast implant materials are prepared in a similar manner from

polytetrafluoroethylene (PTFE) and either vitreous carbon (Proplast I), alumina

(Proplast II), or synthetic hydroxylapatite (Proplast-HA).

The pore size distribution for standard Proplast I, II or HA implant materials is

approximately 50 to 400 micrometers. The pore volume of Proplast implant

materials comprises 70 to 90% of the total material volume.

In vitro biotoxicity studies in animal models have shown Proplast implant

materials to be free from observable systemic or cytotoxic effects.

Numerous uses of Proplast implant materials have been widely documented in

general skeletal reconstructive and cosmetic applications, maxillofacial

augmentation, middle ear surgery, and as a stabilizing coating for

temporomandibular and orthopedic endoprostheses.³²³

[Emphasis added]

[286] What follows is a description of each of the three Proplast materials covered in this

submission: “About Proplast I”, “About Proplast II” and “About Proplast-HA

(Hydroxylapatite)”. The use of each of the three is described as “exclusively for surgical

implantation” with the performance characteristic of “implant stabilization by tissue

ingrowth”.³²⁴Each of the three descriptions carries on to outline some of the physical properties

of the Proplast material being considered.

[287] In the product monograph, after these descriptions of the Proplast materials, there is a

section with the title: “Advantages of Proplast Implant Materials”. This outlines those

advantages as seen by Vitek Inc. as the applicant for the Notices of Compliance.

³²³Ibid at p. 417-418

³²⁴Ibid at pp. 418-419

Page: 97

[288] What none of this does is to distinguish between any specific uses to which any or all of

these devices be they “Block” or “Sheeting” might be put to. This is not surprising. “Block” and

“Sheeting” by their nature are not set for any particular use. Surgeons do not implant “blocks” or

“sheets”. These materials are to be formed or shaped for the particular use to which they are to

be put. This is confirmed by the fact there are other “devices” that are the subject of the

Submission, specifically “preformed” for use as “TM Joint Implants”³²⁵and “Preform Facial

Implants.”³²⁶As already noted the former were not issued Notices of Compliance. The latter

were. This is consistent with the understanding of Richard Lawuyi that the Notices of

Compliance recognized the use of Proplast in facial implants but not orthopaedic ones.

[289] What this speaks to is that the applications for Notices of Compliance for “Block” and

“Sheeting” recognize that these “devices” are not directed to a narrow or specific purpose. Their

purpose is general in nature. These “devices” are “materials” which require refinement before

they are used or implanted. This is different than the applications in respect of “TM Joint

Implants”³²⁷and “Preform Facial Implants”. The purpose of those “devices” is directed towards

assisting with or even resolving particular concerns: facial needs and problems with

temporomandibular joints. This difference is demonstrated by the statements of purpose found

within the three applicable product monographs.

[290] As has already been noted the stated purpose for “Block” and "Sheeting” as found in the

product monograph included as part of the submission is broad. They are to be used “for the

augmentation of either hard or soft tissue and bony contours where congenital or acquired

deficiencies exist.”³²⁸This is to be compared to the purpose or use to which “TM Joint Implants”

and “Preform Facial Implants” are to be put. The proposed product monograph for the first

contains several possible statements, each one directed to a more specific use than the one

utilized for “Block and Sheeting”:

The Total TMJ Implant System is intended for use in patients with severe

malformation and/or destruction of the TMJ anatomy resulting from advanced

rheumatoid arthritis, severe osteoarthritis, ankylosis, fumors, and/or condylar

resorption following surgery for internal derangement. Such joints may exhibit

significant functional impairment resulting in pain, restricted motion, joint laxity,

vertical deficiency and/or malocclusion and thus pose difficult problems in joint

reconstruction.³²⁹

And

Vitek PROPLAST^RTMJ Interpositional Implants are available for post-

meniscectomy use for separating articular surfaces. Such separation may reduce

³²⁵Ibid at pp. 227-359

³²⁶Ibid at pp. 445-570

³²⁷Ibid at pp. 227-359

³²⁸Ibid at p. 417

³²⁹Ibid at p. 328

Page: 98

pain, may improve function, may reduce hypermobility, and may compensate for

a limited decrease in condylar height.³³⁰

And

PROPLAST sheeting laminated to non-porous Teflon may be indicated in

temporomandibular joint surgery where the meniscus is absent or removed. It may

avoid bone to bone apposition and ingrowth with fibrous tissue may provide disc-

like viscoelastic behaviour. (19) The lamination is also available with polyaramid

reinforced Teflon; this form may be selected for those cases where the surgeon

believes added implant strength is desired.³³¹

[291] Even the “Cautions” which are at the beginning of the product monographs demonstrate

this difference. Where the one offered in respect of “Block and Sheeting” is short and to the

point (see para. [282] above) those proposed for or related to “TM Joint Implants” are more

complicated and specific to TMJ implants:

CAUTION: SURGERY OF THE TEMPOROMANDIBULAR JOINT, (TMJ) IS,

BY ITS NATURE, COMPLEX AND CARRIES A CERTAIN LEVEL OF RISK.

INDIVIDUALS USING THE IMPLANTS DESCRIBED HEREIN MUST

HAVE APPROPRIATE TRAINING AND EXPERIENCE FOR SUCCESSFUL

PROCEDURE RESULTS. TMJ RECONSTRUCTION REQUIRES A HIGH

DEGREE OF SKILL, FAMILIARITY WITH JOINT ANATOMY AND

MECHANICS AS WELL AS BIOMATERIALS AND THE USE OF THE

RECOMMENDED INSTRUMENTATION. THE LONG-TERM ACCESS THE

TOTAL TMJ IMPLANT PROCEDURE IS SIGNIFICANTLY TECHNIQUE

DEPENDENT. RESULTS MAY BE COMPROMISED BY PREVIOUS

MULTIPLE JOINT OPERATIONS³³²

³³⁰Ibid at p. 329

³³¹Ibid at p. 330

³³²Exhibit 15 (Vitek Proplast Submission 1988) v. 1 at p. 328.

Within the form of product monograph contained within the submission dealing with TM Joint Implants there are

other statements of caution as follows, all more directed and detailed than the one in respect of “Block and Sheeting:

CAUTION: SURGERY OF THE TEMPOROMANDIBULAR JOINT IS, BY ITS NATURE,

COMPLEX AND CARRIES A CERTAIN LEVEL OF RISK. INDIVIDUALS USING THE

IMPLANTS DESCRIBED HEREIN MUST HAVE APPROPRIATE TRAINING AND

EXPERIENCE. TM JOINT RECONSTRUCTION REQUIRES HIGH DEGREE SKILL,

FAMILIARITY WITH JOINT ANATOMY AND MECHANICS AS WELL AS

BIOMATERIALS. THIS PROCEDURE IS SIGNIFICANTLY TECHNIQUE

DEPENDENT. (at p. 329)

And

Page: 99

[292] In the proposed product monograph dealing with “Preform Facial Implants” there is no

caution offered. Presumably this is because there was no need for one. This would occur in

circumstances where the implantation is not that complex or technique dependent. The use is

more simply stated but nonetheless driven to specific purposes:

Preformed shapes of Proplast are available for use in augmentation and

reconstruction of the chin, zygoma, nose, peri-orbital rim and ear.³³³

[293] As it developed, the Notices of Compliance for “TM Joint Implants” were refused. Those

requested for “Preformed Facial Implants” and “Block and Sheeting” were issued. The idea that

granting Notices of Compliance for Block and Sheeting allowed for their use as

temporomandibular joint implants when applications for Notices of Compliance for products

specifically dedicated to that purpose were rejected is a circumstance where the general would be

able to do what the specific cannot. In the context of treating a delicate and sensitive condition,

where the devices involved are developed at the same time, using the same material, this does

not seem sensible or intended. The question that may remain is whether those referring to or

relying on these Notices of Compliance can reasonably be expected to understand the broader

context of their issuance or whether the product monograph which would accompany the

purchase of the product, in this case “Block” or “Sheeting” was to be a self-standing document,

to be read and understood on its own, and whether, being read that way, it demonstrated that

those devices could be considered for the use as temporomandibular joint implants. I say the

question “may remain” because its relevance depends on whether the temporomandibular joint

implants received by any of the members of the class originated from “Block” or “Sheeting”, the

“devices” that were the subject of the Notices of Compliance that were issued. If, in fact, the

CAUTION: ALTHOUGH THE YOUNGER FEMALE PATIENT APPEARS TO BE THE

PREDOMINANT PRESENTER WITH INTRACTABLE TMJ DISCOMFORT AND

IMPAIRMENT IN SPITE OF CONSERVATIVE THERAPY, ALL AFFECTED PATIENTS

CAN EXPERIENCE CONDYLAR HEAD REMODELLING AND/OR RESORPTION OF

UNKNOWN ETIOLOGY WHETHER OR NOT IMPLANT SURGERY IS PERFORMED. A

SMALL PERCENTAGE OF FEMALE PATIENTS SEEM TO UNDERGO CONDYLAR

HEAD RESORPTION WHICH RESULTS IN PROGRESSIVE CLASS II OCCLUSION

DEVELOPMENT AS A RESULT OF TMJ LOADING OF ANY KIND.(11) THIS

RESORPTION AND PROGRESSIVE CLASS II DEVELOPMENT CAN BE ONGOING

WHEN THE PATIENT PRESENTS FOR TMJ EVALUATION OR CAN OCCUR AFTER

IMPLANT PLACEMENT IN SUSCEPTIBLE INDIVIDUALS. TMJ SURGERY SHOULD BE

AVOIDED IN PATIENTS WITH A HISTORY OF CLASS II BITE CHANGE. CONDYLAR

REMODELING OR RESORPTION CAN COMPROMISE THE RESULT OF SURGERY,

AND, IN SOME CASES, FURTHER SURGICAL INTERVENTION WILL BE REQUIRED. IN

GENERAL, DISCECTOMY AND IMPLANT PLACEMENT SHOULD BE AVOIDED IF

POSSIBLE (at P. 330).

And

CAUTION: USE OF THIS IMPLANT SHOULD BE RESERVED AS AN OPTION ONLY

WHEN MORE CONSERVATIVE MEDICAL AND/OR SURGICAL OPTIONS HAVE BEEN

EXHAUSTED OR ARE NOT INDICATED (at p. 330).

³³³Ibid at p. 550

Page: 100

temporomandibular joint implants utilized were among those dealt with through the request for

recognition of “TM Joint Implants”, the patients involved received implants that were not to be

used. It would not be possible to rely on the approval of Block and Sheeting as demonstrating the

presence of a duty of care, owed by the Crown or, if there otherwise was one, demonstrating it

had been breached by the Crown. There is no evidence that any patient that could be a member

of the class was implanted with “Block” or “Sheeting”, after those devices were in receipt of a

Notice of Compliance.

[294] The cross-examination of Elliot Wayne Tunis describes how orders, on his behalf, were

made:

Q. This photocopy of a page and a notebook appears to document the ordering of,

at least for the entry dated September 26, 1985, document:

The Ordering of a Proplast VITEK 913.46, Fossa, TMJ Prothesis Correct?

A. Yes.

…

Q. I am inferring from that that means that two of these implants were ordered

and received?

A. That’s what I would assume, yes.

…

MR. NEWLAND: And would this be consistent with your experience when you

wish to implant some Proplast Teflon that you ask the hospital for certain kind of

implant?

A. Only if it was something out of the ordinary. If it was an interpositional

implant it was kept in stock. If it was a fossa prosthesis it would be ordered

specifically for a certain case.

Q. I see. Is your evidence that it was basically you would have obtained these

Proplast implants in one of two ways, either the hospital kept a continuous supply

of Proplast implant? That would be the first way, correct?

A. Yes.

Q. And the second way would be that if it were a Proplast implant that was

somewhat less routine, you would specifically ask someone at the hospital if they

could order it?

A. Yes.

Page: 101

Q. And so a Proplast implant, to replace the data disk in a meniscectomy, would

fall into the former kind of category; is that fair?

A. The one that was kept in stock?

Q. Yes.

A. Yes.

Q. And so a fossa prosthesis was something less ordinary and you would make a

specific order for it?

A. Yes

Q. And that order, I think. I don’t know if I got this right, that order would be

made to someone in the hospital administration?

A. I would have told the head nurse of our OR, because she was in charge

obtaining materials we needed. And she would then take that to purchasing or

whoever would be in charge of obtaining those items. I don’t know exactly where

it went. ³³⁴

[295] This exchange was followed by the exhibiting of a “Photocopy of document containing

entry dated September 26, 1985 (the ordering of a Proplast Vitek 913.46 fossa, TMJ prothesis)”.

[296] What is plain from this is that Wayne Elliot Tunis used the devices specifically made to

be used as temporomandibular joint implants. They would not have received Notices of

Compliance but the hospital with which he was associated purchased them and he implanted

them. There is no evidence that he made use of the more general devices, that is, Block and

Sheeting, which he, or someone under his direction, would have had to form and shape so it

could be used as an implant to the temporomandibular joint.

[297] For his part Daniel Tomlak was asked about the product that he used:

Q. Okay. And I thought I heard you say this morning that it had not been FDA

approved. Is that specifically in relation to the, the interpositional implant or the

pre-cut device?

A. Well, again the interpositional implant refers – that’s generic. You put in a

Proplast, silastic sheeting, that’s interpositional. Vitek came out with an

interpositional material that was a laminate and that was Teflon-Proplast. That

was not approved until ’83.³³⁵

³³⁴Transcript, Cross-Examination of Elliot Wayne Tunis on his affidavit sworn August 1, 2007 at pp. 61-64

³³⁵Transcript of Dr. Daniel Tomlak (May 21, 2019) at p. 4

Page: 102

And

Q. And so, would it be fair to say what you were taught, and your view at the time

was that Proplast was the best material available for a disc replacement surgery.

A. Yes. The laminate. The Teflon-Proplast.³³⁶

[298] This comment says nothing about which Vitek Proplast product Daniel Tomlak used after

his return to Canada. It does not matter. 1983 is the year the Daniel Tomlak went to Thunder

Bay. 1986 is the year he attended the conference and, as a result of what he was told in informal

discussions, stopped using Proplast-Teflon. It was not until 1988 that Proplast Block and

Sheeting were granted Notices of Compliance. This happened at a time before the second

submission seeking Notices of Compliance and, accordingly before such notices were issued in

respect of Block and Sheeting. In his evidence, Daniel Tomlak indicated that he did not concern

himself with whether or not the product he was using had received a Notice of Compliance. He

relied on the reputations of the distributor (Instrumentarium Inc.) and its representative. This is

contrary to the statement made in the Submissions of the Plaintiff where it is said that Daniel

Tomlak believed that because the interpositional implants were on the Canadian market they had

undergone an assessment of safety and efficacy by Health and Welfare Canada before being

approved.³³⁷This idea is contrary to the evidence as I understand it. First medical devices are

never “approved”. They receive Notices of Compliance meaning that that they have complied

with the requirements for obtaining such status. Second, Notices of Compliance for

“interpositional implants” were refused. It may be that Daniel Tomlak believed Notices of

Compliance had been issued but it was not because of the actions of the regulator that he was

mistaken, it was because as a result of his faith in Instrumentarium Inc. and its representative he

believed the necessary work had been done.

[299] There is no other evidence from any other doctor who implanted patients in Canada and,

if there are any who did, which device they used, in particular, whether they purchased it as

Block or Sheeting to be shaped and formed.

[300] What about the patients? The representative plaintiff did not testify. Some parts of her

medical records were filed and received by the Court, on consent.³³⁸This material reveals that

during 1988, Kathryn Anne Taylor had a total joint reconstruction using a “Kent-Vitek

prosthesis”. I note that at the time of the first motion considering certification, the motion judge

was of the understanding that the implant the representative plaintiff had received was a “Vitek

TMJ implant”. This was important because it distinguished this case from the one commenced

by Kevan Drady. In that action the claim was struck out, in part because Kevan Drady was

unable to identify the specific kind of implant he had received. Kathryn Anne Taylor could but it

was not one of those that had been the subject of a request for a Notice of Compliance. To put it

simply, the implant received by Kathryn Anne Taylor was not a “Vitek TMJ Implant”. It was a

³³⁶Ibid at p. 7

³³⁷Submissions of the Plaintiff at para. 57

³³⁸Exhibit 46 and Exhibit 72 (which is a transcript of the Examination for Discovery including exhibits to that

discovery which, in turn, include additional medical records)

Page: 103

“Kent-Vitek Implant”. Whatever the difference, it appears that the implant she received may not

have been one of the group of implants used to identify the class. There are among the implants

considered some which include in the name that identifies them the two letters “VK”.

Presumably this indicates “Vitek/Kent but nothing was said that compares “VK” implants to

“Kent-Vitek”. This raises the question as to whether Kathryn Anne Taylor is part of the class.

This issue was raised by the Crown at the first determination of the application for certification:

Counsel for the Attorney General submitted also that Ms Taylor should be

rejected as a representative plaintiff because there was evidence that her implants

contain a unique component and no evidence that it and other Vitek TMJ implants

have any common characteristics. I do not accept the submission. The witness

who referred to the conjunction of Proplast and another component as being

unique in his experience, did not find that it would, or could, be significant in

relation to the issues in the action. His evidence was that it was not "typical" - a

concept that is not part of the criteria for certification in this jurisdiction. By itself,

I do not consider this evidence to be sufficient to disqualify Ms Taylor as a

representative of the class. This finding is without prejudice to any motion the

defendants might bring - with supporting affidavit evidence - in the future for the

examination or discovery of other class members.³³⁹

[301] In any case, the function and impact of this implant placed in the jaw of Kathryn Anne

Taylor was monitored during the years that followed. In a report dated October 1, 1997, Dr.

Gerard Baker observed that:

So far, there has been no clinical or radiographic evidence of local bone and soft

tissue reaction to the Kent-Vitek prosthesis.³⁴⁰

[302] She was seen again by Dr. Gordon Baker on October 5, 2000:

She has an artificial joint being Pro plast Teflon [sic]. She has been monitored

since 1994 for this appliance. We have made the elective decision based on her

excellent function, not to remove this device and replace it with another type of

joint. It is equivocal as to whether the problem today is related to the joint itself,

or the trigeminal neuralgia or a combination.³⁴¹

[303] The next year, 2001 she was seen by Dr. Allan Gordon. He reviewed the medication she

was taking, but his Note also comments:

³³⁹Taylor v. Canada (Health), 2007 CanLII 36645 (ON SC), 285 DLR (4th) 296, 49 CPC (6th) 36, [2007] OJ No

3312 (QL), 160 ACWS (3d) 385 at para. 39

³⁴⁰Transcript of the Examination for Discovery of Kathryn Anne Taylor (April 25, 2017) at Exhibit 4

³⁴¹Ibid at Exhibit 5

Page: 104

She does want to see Dr. Baker because she did have an injury to her jaw in

England.³⁴²

[304] Kathryn Anne Taylor was seen by Dr. Sidney Fireman. By letter dated March 23, 2012,

he reported on “Hitachi Cone Beam CT Imaging” completed on March 16, 2012. In part he

wrote:

A larger field was employed to allow for an assessment of the TMJ’s; this was of

special interest to me and the patient as I had examined her 10 years previously

for this. Advanced degenerative joint disease is evident in the left joint. There is

no suggestion of complication with respect to the attachment of the metal plate on

the right side. Good bone volume is suggested in the edentulous 33-30 for site. I

have screened the data set; there is no evidence of significant abnormality in those

parts of the volume not presented.³⁴³

[305] What is plain from this is that the representative plaintiff received a TMJ Implant

prosthesis which included Proplast in its composition and which was developed or credited, not

just to Vitek Inc. but also to Dr. J.N. Kent who was referred to, during the trial, as a colleague of

Charles Homsy.³⁴⁴Kathryn Anne Taylor was not implanted with “facial Block and Sheeting”.

Moreover, the prosthesis which she received was other than the Vitek Inc. products for which

applications for Noticed of Compliance were applied for and refused.

[306] Trudy Tallon testified. In 1985 she underwent surgery that included the insertion of a

Vitek Proplast TMJ implant. Whether this was cut from Block and Sheeting that was the subject

of a Notice of Compliance or was a preformed implant for which no Notice of Compliance was

issued is not determinable from the evidence that was provided. It was implanted by Dr. William

Dowhos, one of the two surgeons in Thunder Bay with whom Daniel Tomlak worked while

there. ³⁴⁵William Dowhos is the doctor that directed Daniel Tomlak to the head operating nurse

for the purpose of seeing about the purchase of the implants. For a brief period, Daniel Tomlak

oversaw the care of Trudy Tallon.³⁴⁶In the period since, Trudy Tallon has suffered.³⁴⁷The

implant was taken out in 1988. This being so, as with the patients implanted by Daniel Tomlak,

the implanting took place before the Notice of Compliance was granted to Proplast Block and

Sheeting.

[307] At the time the implant was taken out, the oral surgeon, Dr. Symington, told her that the

implant had shattered and that he was unable to extract all the resulting particulate.³⁴⁸She has

undergone a bilateral total joint replacement at the Baylor Medical Center, in Texas. Even with

³⁴²Ibid at Exhibit 6

³⁴³Ibid at Exhibit 8

³⁴⁴This is different than the information provided to the Court of Appeal where the device implanted in the

representative plaintiff was referred to as a “Vitek TMJ implant” (see: Taylor v. Canada (Attorney General), supra

(fn. 35) at para. 6)

³⁴⁵Transcript of Trudy Tallon (April 5, 2019) at p. 10

³⁴⁶Ibid at p. 14

³⁴⁷Ibid at pp. 13-16

³⁴⁸Ibid at pp. 17 and 24

Page: 105

this, she remains in a state of pain.³⁴⁹Trudy Tallon is reliant on a soft liquid diet.³⁵⁰At some

point in the early 1990’s she and her husband, David Bullough, who also gave evidence in this

trial, contacted the United States Food and Drug Administration. They were referred to Health

and Welfare Canada. Generally, over the course of 1994-2001 each year, they telephoned Health

and Welfare Canada in order to obtain information on Vitek Proplast implants. ³⁵¹They were

told that there was nothing that was available but that Health and Welfare Canada would contact

them if any information was received. These telephone calls represent direct contact between

Trudy Tallon and Health and Welfare Canada.

[308] Brenda Birinyi appeared as a witness at the trial. Over the years she has had multiple

temporomandibular joint surgeries, many of them in the United States and, latterly, in Canada.

Each of the surgeries conducted in the United States were performed by Larry Wolford, referred

to by Daniel Tomlak as among the top five oral maxillofacial surgeons in the United States.

Among those surgeries, on December 30, 1986, Larry Wolford performed a “Right

temporomandibular joint arthroplasty and insertion of [a] Proplast-Teflon implant”.³⁵²The

device failed and had to be removed. Larry Wolford replaced it with a silastic implant. He did

this on February 5, 1987 but it also failed and was removed on August 1, 1987.³⁵³It is difficult to

see how a Canadian regulator, in this case Health and Welfare Canada, could be liable, in any

way, for the implanting of a maxillofacial device in the United States, under the auspices of the

regulatory scheme in place in that country. In the circumstances of this case, it cannot be.

[309] On February 17, 1989, at the Credit Valley Hospital in Mississauga, Ontario, a Proplast-

polyethylene glenoid fossa implant was placed in the temporomandibular joint of Brenda Birinyi

by Dr. D. S. Psutka. The prosthesis utilized was identified in the following sentences:

Attention was returned to the preauricular wound using the 6 mm medium right

sided proplast-polyethylene glenoid fossa implant, the implant was impregnated

with Ancef solution and then custom trimmed with a large scalpel. After

idealizing the fit and customizing the fit of this implant with trimming and

banding the prosthesis was secured to the zygomatic arch with a circum-

zygomatic 26 gauge wire and a 2 mm Titanium bone screw. This gave excellent

stabilization of the glenoid fossa prosthesis. Attention was then directed towards

customizing the fit of the condylar prosthesis. The Vitech [sic] 45 mm right sided

condyle was selected for this patient, benders were used to maximize the contact

between the condylar prosthesis articular surface and of the articular surface of

the glenoid fossa prosthesis.³⁵⁴

[Emphasis added]

³⁴⁹Ibid at pp. 24-26, 30-31 and 33

³⁵⁰Ibid at p. 33

³⁵¹Ibid at pp. 21-23 and see Transcript of David Bullough (April 5, 2019) at pp. 39-41

³⁵²Exhibit 25 T. 2A p. 7

³⁵³Transcript of Brenda Birinyi (April 25, 2019) at p. 91-94

³⁵⁴Exhibit 25 T. 3A (Operative Record, Feb. 17, 89) at p. 3

Page: 106

[310] This was not “Block” or “Sheeting”. The description is of a pre-cut, preformed implant

specially directed to use as a temporomandibular joint implant. During the course of the same

procedure “silastic sheeting” was used as part of the reconstructive arthroplasty performed on the

left side:

Using 0.6 silastic sheeting a custom silastic meniscus implant was fabricated and

ligated to the zygomatic arch using 26 gauge wire.³⁵⁵

[311] Silastic is not Proplast. Silastic sheeting is not Proplast sheeting. Silastic had been used

prior to Proplast products. Proplast was thought to be an improvement because it provided better

stability through the ingrowth of tissue once the implant was in place. Whatever was implanted

as recorded in this quotation, it was not the “Sheeting” that was the subject of the Notices of

Compliance issued to Vitek Proplast “facial Block and Sheeting”.

[312] A second surgery was performed June 16, 1989. The work done included the “custom

fabrication and installation [of] Vitek II glenoid fossa prothesis left TMJ” and “customization

and installation Vitek II left condylar prothesis”. There is no reference to “Block” or “Sheeting”.

I am unaware of any reference, in the Record of this proceeding to “Vitek II”. There is mention

of “Proplast II” and to “VK II”. Regardless of any confusion this may appear to create, it is clear

that the “custom fabrication” and “customizing” does not refer to remodelling using “Block” or

“Sheeting” as the base. It refers to the “customizing” of a preformed Vitek Proplast

temporomandibular implant.

[313] There is no suggestion, in the evidence, that Brenda Birinyi or anyone on her behalf

telephoned, spoke to or wrote to representatives of Health and Welfare Canada.

[314] Katherine Madden was another patient who testified at the trial. Like Trudy Tallon and

Brenda Birinyi she has had multiple procedures associated with her temporomandibular joint.

She has, over the course of her life, undergone a total of 22 such surgeries.³⁵⁶None of them

involved Proplast. The medical records that were filed reveal that by December 11, 1987 she had

already had four joint procedures. On that day, she had “a bilateral TMJ reconstruction including

meniscectomy, silastic implants, dermal graphs to the joints bilaterally, and placement of arch

bars”³⁵⁷[Emphasis added]. She was discharged on December 15, 1987 but three days later, on

December 18, 1987 the same surgeon, Dr. W. Dobrovolsky, operated again:

OPERATION: Bilateral TMJ reconstruction including eminectomy, condylar

shave, menisectomy, silastic fossa implant, with harvesting of dermal graphs from

left buttock.

…

³⁵⁵Ibid at p. 2

³⁵⁶Transcript of Katherine Madden (April 25, 2019) at p. 17

³⁵⁷Exhibit 23 T. 4 (FINAL SUMMARY, Rept. date: 22, Feb. 88) p. 2

Page: 107

The area was copiously irrigated and soft tissue margins were trimmed. At this

stage, silastic faucet implants were fit from within the silastic sheeting and

attached to the superior aspect of the joint, namely the glenoid fossa via three

lower screws through the zygomatic arch. The joints were functioned to ensure

range of motion on the condylar head was within the confinds [sic] of silastic and

the silastic was trimmed so as not to impinge on the ear canal.³⁵⁸

[Emphasis added]

[315] During 1988, it was proposed that Katherine Madden receive a Vitek Proplast Teflon

implant. On the scheduled date Katherine Madden had strep throat and the surgery did not take

place.³⁵⁹She came under the care of Dr. D.S. Psutka, the same surgeon who operated on Brenda

Birinyi at the Credit Valley Hospital. On December 9, 1988 he removed the implant placed by

Dr. W. Dobrovolsky and replaced it with another also made of silastic sheeting:

Silastic sheet material was then cut to fabricate a custom meniscus implant.³⁶⁰

[316] Katherine Madden got embroiled in a debate as to the efficacy of Proplast implants. She

attended a seminar in Oakland California about the dangers of Proplast.³⁶¹At the end of May

1989, she was seen by D.S. Psutka. He “wanted to put the Vitek Proplast Teflon Implant into

me.”³⁶²Katherine Madden told the court that she advised D. S. Psutka of what she had learned at

the conference. In his view as expressed by her, Katherine Madden had been “brainwashed”.³⁶³

Katherine Madden went on to explain that two days after her appointment with D.S. Psutka, she,

with the assistance of her mother, telephoned Health and Welfare Canada to warn them about the

dangers “[w]ith the Silastic but also to inform them about the Proplast Teflon”.³⁶⁴They raised

Proplast even though Katherine Madden did not have a Proplast implant because she “didn’t

want other people to suffer”.³⁶⁵During the summer of 1989 they telephoned Health and Welfare

Canada four times. They were put on to Dr.William Freeland. They were trying to “raise the

alarm” with respect to Proplast and silastic. They made further calls to Health and Welfare

Canada in 1990.³⁶⁶

[317] During August 1990 Katherine Madden had a further surgery; this one in San Antonio

Texas by Dr. Robert L. Christianson. The silastic implant and excess bone were removed and

fresh prostheses implanted. In evidence she described this as a stock Morgan implant made of

titanium and acrylic.³⁶⁷

³⁵⁸Ibid (OPERATIVE NOTE, Rept. date: 18/12/87) at pp. 1 and 3

³⁵⁹Transcript of Katherine Madden (April 25, 2019) at p. 21

³⁶⁰Exhibit 23 T.5 (OPERATIVE RECORD, Date of Operation: Dec. 9, 1988) at p. 3

³⁶¹Transcript of Katherine Madden (April 25, 2019) at pp. 39-42

³⁶²Ibid at at p. 43

³⁶³Ibid at p. 43

³⁶⁴Ibid at pp. 52-53

³⁶⁵Ibid at p. 72

³⁶⁶Ibid at p. 64

³⁶⁷Ibid at p. 65

Page: 108

[318] Following this surgery Katherine Madden and her mother made further efforts to

communicate with Health and Welfare Canada. They wanted to “raise the alarm about the

silastic and again about Proplast” because of what they had learned from Robert L. Christianson.

In response to a request made during that call they sent the material they had been given in

Texas.³⁶⁸There were responses. Katherine Madden received a fax about a warning in Canada.

She could not recall what it said. She also could not recall but may have received a letter from

the Medical Devices Bureau, dated October 28, 1994, which stated its purpose to be to inform

the reader of “concerns with alloplastic TMJ implants”.³⁶⁹

[319] Judy Munro received a Vitek Proplast implant. It was put in place, in Thunder Bay by

William Dowhos. This took place in late 1985. Judy Munro was told that the implant was a

“Teflon plate”. In evidence, at trial she said she “…didn’t really understand what that meant.”³⁷⁰

Subsequent to her appearance, and with the consent of counsel for the Crown, an Operative

Record in respect of this surgery was made an exhibit in this trial albeit under the name Judy

Corbett. It was never reviewed by any witness. I am left to interpret it for myself. It includes the

following sentence:

The anterior portion was also cauterized and the Proplast interpositional placed,

cut to fit properly and sutured with the use of 3-0 Silk burr holed being placed

into the zygomatic arch.³⁷¹

[Emphasis added]

[320] Daniel Tomlak referred to the term “interpositional” as generic (see para. [297] above):

when something is placed between the two articulating bony structures (the condyle and the

fossa) to replace the meniscus it is “interpositional”. It could be pre-cut for the purpose, still

requiring some further cuts for proper fitting or it could be cut from Block or Sheeting. Thus, the

description from the operative note is not helpful. If it was formed from Block or Sheeting; these

“devices” were not, at the time subject to a Notice of Compliance. However, there is nothing to

suggest the circumstances of Judy Munro were any different than those the patients implanted by

Daniel Tomlak.

[321] Judy Munro is an example of the limited impact this class action can have regardless of

the ultimate result. There is nothing that suggests that Judy Munro was implanted with a device

that had received a Notice of Compliance. Her complaints began immediately after the surgery.

She continued to see her family doctor. She did not seek a second opinion from an oral surgeon

as to her problems until 1993 when she visited the Mayo Clinic in Minnesota. On her return she

saw both her family doctor and her dentist. Neither knew “anything about it.”³⁷²I take “it” to

refer to the recall that had taken place in 1990 and will be reviewed later in these reasons. This

³⁶⁸Ibid at pp. 69-71and Exhibit 23 T. 1

³⁶⁹Transcript of Katherine Madden (May 14, 2019) p. 26-27 and Exhibit 36

³⁷⁰Transcript of Judy Munro (April 3, 2019) at p. 2

³⁷¹Exhibit 5

³⁷²Transcript of Judy Munro (April 3, 2019) at p. 9

Page: 109

leaves open the question of whether, and to what extent, the work of the various health

professionals involved might have contributed to her difficulties. The issue is more acute in a

situation such as this, where the liability to be imposed on the Crown, should the action succeed,

is to be restricted to its proportionate share of the damage.

[322] By this time the Health Protection Branch had set up a Medical Devices hotline. Judy

Munro called that number. It seems that Judy Munro called a variety of individuals and

eventually spoke to Jim Moore, described as a Compliance Officer with the Health Protection

Branch. This resulted in a series of letters from the branch to a lawyer who had been retained by

Judy Munro.³⁷³

[323] Judith Anne Logan also testified. She received an implant on March 26, 1985 which is to

say before any Notice of Compliance was issued. The surgery took place at the Chedoke-

McMaster Hospital. At the outset of her evidence the question of which implant she had received

was raised. This was well before the submissions seeking Notices of Compliance had been made.

Judith Anne Logan had been the representative plaintiff in this action. Judith Anne Logan was

implanted with a “Teflon Proplast meniscus [that] was then tailored to fit the fossa”.³⁷⁴The

reference to this implant as a “meniscus” that was “tailored” suggests that this was not “Block or

Sheeting” but was a preformed meniscus replacement to be used as a temporomandibular joint

implant and augmented to fit the patient.

[324] The upshot is that there is no direct or specific evidence that any prospective class

member was ever implanted with Block and Sheeting in a temporomandibular joint and, in any

case, there is no evidence any patient received such an implant after either of Block or Sheeting

had been issued a Notice of Compliance. This raises the question as to whether there is anyone

who can claim negligence in the respect of the review and issuance of the Notices of

Compliance.

[325] Given the failure to identify a single person who received “Block” or “Sheeting” as a

temporomandibular joint implant or a single professional (doctor or dentist) who implanted these

materials, it does not matter what the product monograph says because no one has been

identified as having been misled by it.

[326] Even so, I go on to consider the alternative proposition.

[327] On the assumption that there is a person who received, or a doctor who implanted, Block

or Sheeting in a temporomandibular joint, what does the product monograph for Block and

Sheeting say that misrepresents the circumstances and could have misled the reasonable reader?

In this case the reader must surely be the health professionals, not the patients. This

understanding was confirmed by the evidence of Nirmala Chopra who testified that the product

³⁷³Exhibits 1, 2, 3 and 4

³⁷⁴Transcript of Judith Anne Logan (May 16, 2019) at p. 35 referencing Exhibit 40 (Various Records of Dr. R.

Harper) at p. 1

Page: 110

monograph was intended to go to the oral surgeon who “decides whether or not the

contraindications apply to a particular patient”³⁷⁵

[328] Pierre Blais in discussing “product warnings” said much the same thing:

THE COURT: Well, can I just ask a question about this before you go on. These

product warnings, I take were, we could be talking about two things that we’ve

discussed, I suppose. One is the sort of Information Letters that have been sent

out explaining concerns. Is that a product warning?

A. No, no, Your Honour. A product warning is something that is built into the

product itself. We call it – generically, we call it a product insert. A product

insert will have warnings just like a drug.

THE COURT: Is this like drugs or like cigarettes?

A. With cigarettes, yes, you're correct.

THE COURT: All right, so these warnings would be, I take it, presented to the

people who unpacked the device.

A. They were part and parcel of the submission.

THE COURT: Oh, I see. I mean, I’m sorry, this is something that the department

– that the premarketing people were told by the manufacturers as it came in.

A. Yes.

THE COURT: So is this what we’ve been referred to earlier as contraindications?

A. Product warning has a very specific name in this business and it’s labeled – it

establishes the limit of the product. The claims, what it can’t do, what it may do,

how you may get around it to recover your patient....

THE COURT: Sorry, what product can do?

A. What it can do...

THE COURT: Yeah.

A. ...in terms of injury, how it is to be treated by a physician who encounters it as

a problem, how the product could misbehave under some circumstances. In a

way you could almost call it the birth certificate of a...

THE COURT: Well...

³⁷⁵Evidence of Nirmala Chopra (April 11, 2019) at p. 146

Page: 111

A. ...product.

THE COURT: ...let me just see if I understand what this actually is. This is some

explanation of the limits of the product which are provided by the manufacturer

distributor to the regulator at the time of submission is made under Part V?

A. Yes.

THE COURT: With the intention that if the Notice of Compliance is issued, that

label will be passed on to whoever opens or looks at the package.

A. Yes.

THE COURT: And the person who opens and looks at the package would be

presumably be the doctor or the hospital.

A. Yes.

THE COURT: Okay. To put it another way, we’re not anticipating here that the

patient is going to open the package and read the label, it’s the doctor or the

hospital or surgeon that’s going to do so.

A. No, but that needs a small qualification.

THE COURT: No, what? Sorry, no, yes, I’m right?

A. The, the product insert or the instructions for use for most high-risk products

do not reach the patient, ever.

THE COURT: Just a minute.

A. They stop at the physician.

THE COURT: Okay. Sorry, it sounded like you want to keep going.

A. Now, there is another document that is built into the product by the

manufacturer which is supposed to be, what is the minimum that can be

transmitted to the patient so as to be sure of safety and efficacy.

THE COURT: And who is it that’s supposed to transmit that minimum material

to the patient?

A. The surgeon or the institution or the followup specialist, the nurse. There

could be other professionals and paraprofessionals.

THE COURT: Okay. I think I got it now. Thanks. Just a minute. Okay.

Page: 112

MR. LEGGE: Thank you, Your Honour³⁷⁶

[329] In the Product Monograph prepared for “Block and Sheeting”, following its discussion of

the three Proplast materials (“About Proplast I”, “About Proplast II” and “About Proplast-HA”),

there is a review of the “Advantages of Proplast Implant Materials”. Among them is: “Carvable--

easily sculpted to desired shapes with sharp scalpel”.³⁷⁷This confirms that “Block” and

“Sheeting” are not finished implants but materials to be shaped and sculpted. From there, the

product monograph goes on and refers to “Indications” and “Contraindications” for the use of

those materials. Among the “Contraindications” are the following:

Proplast is NOT indicated for use in applications where the material will be

subject to immediate postoperative compressive loading or in applications where

there is insufficient underlying bone or tissue to prevent collapse of the implant in

the event of external pressures,

and

Proplast is NOT indicated for use in filling voids on articulating bony surfaces.

Proplast is not indicated to use as implant itself in weight-bearing or articulating

joint applications where the implant itself would be subject to immediate post-

operative compressive loading.

[330] In their examinations, at trial, counsel for the Plaintiff were at some pains to demonstrate

that those who implanted the TM Joint implants of concern were careful to instruct their patients

that, for a period of time immediately after the surgery, care in eating should be taken to avoid

any loading on the temporomandibular joint. Counsel for the Plaintiff rely on this to say that the

direction found in the “Contraindication” was met. This understanding provides the foundation

for the idea that, if a contraindication has been responded to the use to which the implant is put

can be taken as authorized.

[331] Surely, this is not the case.

[332] The “Indications” found in the product monograph include:

For use as an implant itself where augmentation of either hard or soft tissue is

desired,

and

For augmentation of bony contour where congenital or acquired deficiencies

exist,

³⁷⁶Transcript of Pierre Blais (May 1, 2019) at pp. 39-41. (There is a discussion with Pierre Blais concerning

“Contraindications” in the Transcript of Pierre Blais (May 6, 2019) at pp. 86-87 but it does not contribute to an

understanding of the limits or meaning of the word.)

³⁷⁷Exhibit 15 v. 1 p. 419

Page: 113

and

For augmentation or stabilization by tissue in growth is desired.

[333] If the premise is accepted, there need be no additional or continuing consideration by the

manufacturers, distributors, hospitals or healthcare professionals as to whether any prospective

use is appropriate for the product being considered. If the implant is to augment tissue or bone

and will not result in any immediate post operative compressive loading and these indications are

taken to be enough to confirm its use for any of the broad array of purposes these generalized

statements may encompass, it no longer matters what the particular use may be: orthopaedic,

facial, cosmetic or whatever. This conclusion does not fit where the regulatory scheme does not

perceive the “approval” of anything:

It must be noted that there is no authority or mechanism under the Food and

Drugs Act to approve a medical device prior to its sale in Canada. It is the

responsibility of the manufacturer to ensure that the regulatory requirements are

met.³⁷⁸

[334] During the course of the trial, the absence of authority to “approve” was acknowledged

by all parties. A use which falls within the terms of an “Indication” and outside the parameters of

a “Contraindication” is not thereby approved for that use. If it were otherwise, a regulator would

be left in a circumstance where it could only provide Notices of Compliance to “new devices”

for specific and directed uses. It would be a de facto (an actual, real and effective) approval. This

would be contrary to the policy of attempting to make available to the public products that hold

out the possibility of relief albeit while recognizing that there may remain a measure of risk (that

is a balance between safety and efficacy). This understanding would place a responsibility on the

regulator that the regulatory scheme does not allow for and remove, from the health

professionals, obligations as to the appropriateness of treatments that it leaves to them.

[335] This position promotes the question of what should be taken from the use of the words

“Indications” and “Contraindications”. What do these words mean, in the circumstances that

they are being used? No one was asked to explain their meaning as used in a product monograph.

I turn to a dictionary for the “plain and ordinary” meaning:

Indication: 1a: something that serves to indicate b: something that is indicated as

advisable or necessary 2. the action of indicating.

[336] To understand this definition requires a further understanding of the meaning of the word

“indicate”:

Indicate: 1a: to point out or point to b: to be a sign, symptom, or index of (the

high fever indicates a serious condition) c. To demonstrate or suggest the

³⁷⁸Exhibit 48 (Guide to the Preparation of a Submission Pursuant to Part V of the Medical Devices Regulations) at

p. 3

Page: 114

necessity or advisability of (indicated the need for a new school) 2. To state or

express briefly (indicated a desire to cooperate)

…

Contraindication: something (as a symptom or condition) that makes a particular

treatment or procedure inadvisable.³⁷⁹

[337] There is nothing in these meanings that point to anything being approved or prohibited.

“Indications” point to things from a positive perspective; something is “advisable”. In this case it

cannot be asserted that an implant made from Proplast Block or Sheeting was, from a medical

point of view, “necessary” for the treatment of any person that required bone or tissue

augmentation. No one has suggested there were no other treatment approaches available or that

this was the only one that could, and would, succeed in respect of any of the problems associated

with these issues. “Contraindication” looks at things from the negative perspective. The

treatment is inadvisable where there will be immediate post operative compressive loading.

Being inadvisable is not a prohibition. In the context of this case, that contraindication says only

that one should be careful in using Proplast “Block” and “Sheeting” where such loading may

exist. It does not say that this is the only risk in using this material; that is, that absent immediate

post operative loading there is no risk to using it where tissue and bone augmentation is desired.

[338] Accordingly, even if there was an identified party implanted with something “carved

from” Proplast “Block” or “Sheeting”, the product monograph does not demonstrate a definitive

determination that, with the Notices of Compliance being issued, the regulator was providing a

systemic or blanket allowance for their use as temporomandibular joint implants.

[339] Before leaving this area, it may be important to note that Richard Lawuyi, who was

responsible for the review, never read the product monograph. He saw it as promotional material

rather than as a document guiding the user as to its use and associated risks. How can we be sure

that Richard Lawuyi properly evaluated the “safety and efficacy” of these products if he did not

review this material? I note that the product monograph was not the only place in the submission

that these statements of “Indication” and “Contraindication” occur. They are stated at the first

page of the Submission concerning “Block and Sheeting” that comes after the Table of Contents

and the list of applicable devices. That is to say they are repeated separately from the Product

Monograph. They are part of the stated “Purpose” of these “devices”.³⁸⁰There was no suggestion

that Richard Lawuyi did not review and consider these statements in that context. They were

specifically reviewed with him in the course of his being cross-examined.³⁸¹

[340] Among other things, this exchange establishes that the contents of the package in which

medical devices are to be delivered includes statements that advise as to the limits to which the

product should be put and that the advice is directed to medical professionals engaged in that

Webster, Incorporated

³⁸⁰Exhibit 15 v. 1 p. 366-367

³⁸¹Transcript of Richard Lawuyi (May 28, 2019) at pp. 96

Page: 115

use. Product monographs are intended to be included in the packaging and do provide that

advice. The covering letter to Gene L. Fagelson dated July 11, 1988 which enclosed the Notices

of Compliance for “Facial Block and Sheeting” noted:

Section 39 of the Medical Devices Regulations requires that all manufacturers

submit samples of the product monograph, labels, package inserts, product

brochures and file cards before the product is advertised or sold.³⁸²

[341] The primary responsibility for the content of any product monograph lies with the

manufacturer or distributor, that is the party seeking and requesting the issuance of a Notice of

Compliance.

[342] The claim that the Crown should be found to have been negligent rests not only on the

allegation of error in respect of those Proplast products for which Notices of Compliance were

issued but also in respect of those for which they were not. I return to the “special case” heard by

the Court of Appeal and to its decision released July 6, 2012. In doing so I remind the reader

that, at its root, this was a pleadings motion. The facts are to be taken as proved or capable of

being proved:

Ultimately, I come to this point. It is not clear to me that Ms. Taylor will at the

end of the day succeed in making out a private law duty of care owed to her by

Health and Welfare Canada. However, bearing in mind that at this stage the

allegations must be assumed to be true and must be read generously, and also

having regard to the dynamic nature of the jurisprudence, it is not plain and

obvious that the claim as pleaded is bound to fail for want of a private law duty of

care. The courtroom door cannot be closed to Ms. Taylor and the other members

of the class at this stage.³⁸³

[343] The decision of the Court of Appeal noted:

Reading Ms. Taylor’s pleadings generously, they allege that between 1988 and

1990 Health and Welfare Canada repeatedly misrepresented the safety of the

implants Ms. Taylor and others received by wrongly representing that those

implants had received a notice of compliance….³⁸⁴

³⁸²Exhibit 16 p. 88, Exhibit 12 T. 32 p. 13 and Exhibit 56 T. 18 (after the green sheet)

³⁸³Taylor v. Canada (Attorney General), supra (fn. 35) at para. 120

³⁸⁴Ibid at para. 110: The paragraph goes on:

… The pleadings further allege that when Health and Welfare Canada became aware of its

misrepresentation in 1990, it failed to correct that misrepresentation despite the knowledge that

the implants were being improperly imported and sold in Canada and that there was strong and

growing evidence that the implants were unsafe and caused serious harm to users. These

allegations, taken in combination, in my view, describe a relationship between Health and

Welfare Canada and the users of those implants that is different from the relationship that exists

between Health and Welfare Canada and consumers of medical devices at large. The more

Page: 116

[344] As I read the decision, this conclusion was at the centre of, if not fundamental to, the

determination it was not “plain and obvious” that the action could not succeed.

[345] Now, at the end of the trial, what is there that supports the proposition that the Crown

“repeatedly misrepresented” that the implants received by the representative plaintiff “and

others” had been issued Notices of Compliance when they had not? There is only one document

that suggests this could have happened. On August 25, 1989, which is to say just over one year

since the letter of July 11, 1988 advising of the grant of Notices of Compliance for “facial Block

and Sheeting” and just less than one year since the letter of September 2, 1988 confirming that

further more particular information was required to establish the safety and efficacy of “Proplast

T.M. Joint Implant[s]”, Information Letter 765 was released by the Health Protection Branch. It

was addressed to “Manufacturers and Distributors of Medical Devices.” Its stated purpose was:

It has been the practice of the Health Protection Branch to issue, on an annual

basis, a list of new devices for which Notices of Compliance have been issued.

The attached document is an update of Information Letter 751 and includes those

devices for which Notices of Compliance were issued during the period January

1, 1988 to December 31, 1988.³⁸⁵

[346] The Information Letter is accompanied by a 60 page list of devices, broken down by

category, that had been granted Notices of Compliance over the 1988 calendar year. Included on

page 20 under the heading “Musculoskeletal System/Systeme Musculo-Squelettique” are

products attributed to Vitek Inc. for which it was said Notices of Compliance had been issued.

Four on the list that appear under three headings are:

Proplast HA:

TMJ Fossa Prosthesis Type VK

Proplast HA/UPE:

TMJ Fossa Prosthesis Type VK

Fossa Prosthesis Type VK

Proplast HA:

TMJ Condylar Prosthesis Type VK

difficult question is whether the allegations create a sufficiently close relationship to give rise to

a private law duty of care.

I will consider the further allegations as these reasons proceed.

³⁸⁵Exhibit 12 T. 35, Exhibit 56 T. 15 (Information Letter 765)

Page: 117

[347] This group includes only some of the many devices for which Vitek Inc. applied for

Notices of Compliance as “TM Joint Implants”. The Record includes a list of Vitek Inc.

products. It is broken down into separate listings of those granted and those refused a Notice of

Compliance.³⁸⁶The list of those granted a Notice of Compliance is a copy of the Notice of

Compliance. The list of those without Notices of Compliance includes the four identified in the

Information Letter as having received Notices of Compliance when they did not. These four, in

turn include:



four devices identified as Proplast HA TMJ Fossa Prosthesis, Type VK (813.06,

813.07, 813.08, 813.09)

four devices identified as Proplast HA/UPE TMJ Fossa Prosthesis, Type VK

(813.16, 813.17, 813.18, 813.19)

four devices identified as Proplast HA TMJ Condylar Prosthesis, Type VK

(813.61, 813.62, 813.67, 813.68)

There is no grouping for “Proplast HA/UPE Fossa Prothesis Type VK” without

the reference to “TMJ”.

[348] These are the only ones that Information Letter 765 identifies, incorrectly, as having been

issued Notices of Compliance when they were not. There are other Proplast TM Joint Implant

devices produced by Vitek Inc. that did not receive Notices of Compliance. The Information

Letter does not refer to them as having received Notices of Compliance. On the list (as opposed

to the Information Letter) they, along with the four improperly identified on the Information

Letter, are shown as not having been granted Notices of Compliance. These are:



six listed as Proplast HA Interpositional Implants, Non-Porous Teflon Laminate

Concave-Trapezoidal Shape w/Articular Eminence Extension,

three listed as Proplast II Interpositional Implant, Non-Porous Teflon Laminate

Concave-Trapezoidal Shape w/Articular Eminence Extension 2/Box,

three listed as Proplast II Interpositional Implant, Non-Porous Teflon/ Polyaramid

Fabric Laminate, Concave-Trapezoidal Shape w/Articular Eminence Extension,

2/Box



four listed as TMJ Glenoid Fossa Prosthesis, Type VK, and

four listed as Proplast II/UPE TMJ Glenoid Fossa Prosthesis, Type VK

[349] I go through this now to establish that any direct reliance on the Information Letter, and

the error it contained, as establishing the connection necessary to demonstrate that a duty of care

³⁸⁶Exhibit 12 T. 32, Exhibit 56 T. 16

Page: 118

is owed to any particular member of the class would have to be specific to one of the four types

of implant that were the subject of the error. I mean by this that the class member or those

involved in treating that class member relied on the misrepresentation found in the Information

Letter and on that basis put in an implant that had not received a Notice of Compliance. The

only other way this limited mistake could be the foundation for a finding that the requisite duty

of care was in place would be to translate it into a general misrepresentation that is attributable to

all of the Vitek Proplast TM Joint Implants:

The nature of any representations made by the regulator, and the nature of any

reliance placed on those representations by the plaintiff, are part of the entirety of

the circumstances to be considered in determining the directness of the

relationship between the regulator and the plaintiff. Representations made

specifically to a plaintiff and relied on by that plaintiff can clearly forge a direct

connection between the regulator and the plaintiff. General representations made

by the regulator to the public and relied on by the plaintiff as a member of the

public do not, standing alone, create a direct relationship. However, general

representations and reliance on those representations can, in combination with

other factors, create a relationship between the regulator and the plaintiff that is

sufficiently close and direct to render it fair and just to impose on the regulator, in

the conduct of its duties, an obligation to be mindful of the plaintiff's legitimate

interests.³⁸⁷

[350] What are the circumstances here? How is it this error was made and what evidence of

reliance by members of the class can be established? The error was traced back to a database that

recorded the regulatory status of various and many devices for which Notices of Compliance had

been requested:

There was a database that contained submissions and submission tracking system,

and basically you run a report to say between date A and B which one have

received a status notice of compliance and run the printout, and then you reformat

that a million time[s] because PCs were not on anybody's desk at that time.³⁸⁸

[351] A printout was exhibited. The four devices noted in the Information Letter as having been

granted Notices of Compliance are shown as “ACCEPTED”. They should not have been. The

error was in the input to this database. How this happened was not, nor it seems can it be,

explained. The Submissions of the Plaintiff contains the following paragraph and footnotes

which summarize the support for this assertion³⁸⁹:

Mrs. Chopra was unable to explain why four devices were shown in the database

print out as having been approved on September 2, 1988.³⁹⁰Similarly, Mr. Boulay

had no information on why TMJ implants were shown as having been approved in

³⁸⁷Taylor v. Canada (Attorney General), supra (fn. 35) at para. 118

³⁸⁸Transcript of Louis Boulay (June 11, 2019) at p. 61

³⁸⁹Submissions of the Plaintiff at para. 371

³⁹⁰Transcript of Nirmala Chopra (April 23, 2019) at pp. 94-96

Page: 119

Information Letter 765.³⁹¹He testified that the source of the information in

Information Letter 765 was the Health Canada database that “contained

submissions and submission tracking system”.³⁹²Mr. Boulay confirmed on

examination that no one outside the Pre-Market section had access to the

database.³⁹³Mr. Boulay could only speculate that “[t]here was an error in data

entry in the internal database”.³⁹⁴Mr. Boulay confirmed that Information Letter

765, dated August 25, 1989, included a number of TMJ implants³⁹⁵….

[352] Lindsay Blaney said the same thing. It was Francine Jacques (Gaudette) who told her

there had been a coding error.³⁹⁶

[353] Despite this the Submissions of the Plaintiff treat these specific temporomandibular joint

implants as having been approved. The following specific submission is made:

In addition, the Plaintiff submits Health Canada was negligent in granting NOCs

to the TMJ devices that received NOCs on September 2, 1988.³⁹⁷

[354] As the letter of September 2, 1988 made clear that Notices of Compliance for Proplast

T.M. Joint Implant (Submissions numbered MSO39288 to MSO40188) were refused on that day,

³⁹¹Transcript of Louis Boulay (June 12, 2019) at pp. 5-26

³⁹²Transcript of Louis Boulay (June 11, 2019) at pp. 60-61

³⁹³Transcript of Louis Boulay (June 12, 2019) at p. 26

³⁹⁴Ibid at pp. 6-7

³⁹⁵Ibid at pp. 5-26

³⁹⁶Transcript of Lindsay Blaney (September 18, 2019) at pp. 82 and 106:

Q. Now, when you say there was a coding error what do you mean by that?

A. I would never be able to explain in detail what that means. I was told that, you know when I

found out about this, that there had been some type of entry error, coding error. And so I don’t

know more than that.

Q. Do you recall who told you that?

A. I think it was Francine Jacques.

…

Q. The information letter that spoke of Notice of Compliance in fact having been issued when

we spent some time earlier this afternoon talking about Fossa, 3 Fossa and one condylar VK.

And the Fossa and condylar implants we were speaking of earlier this afternoon. Do you recall?

A. Yes I do.

Q. And this was the coding error issue, those implants. Your position is they were never given a

Notice of Compliance?

A. They were never given a Notice of Compliance.

³⁹⁷Submissions of the Plaintiff at para. 364

Page: 120

not granted (see para. [268] above). How can the Plaintiff say otherwise? Lindsay Blaney was

National Co-ordinator for the Field Operations directorate from 1990 to 1994. In that capacity

she acted as a liason with the regional offices and program bureaus, one of which was the

Medical Devices Bureau. From 1994 to 1998 she was a scientific evaluator for that bureau.

Lindsay Blaney was referred to a handwritten note she had prepared on November 9, 1994.³⁹⁸

Whereas she had previously testified that only facial implants had received Notices of

Compliance, this note identified three temporomandibular joints implants as having been

approved. These were: (1) MS039488 being Proplast HA TMJ Fossa Prosthesis Type VK, (2)

MS039588 being Proplast HA/UPE TMJ Fossa Prosthesis Type VK and (3) MS039688 being

Proplast HA/UPE Fossa Prosthesis Type VK. Lindsay Blaney was unable to explain how it is

that this document showed these devices as having been approved. The answer is they were not

approved. They are three of the four devices incorrectly recorded as having been approved in

Information Letter 765.

[355] The plaintiff insists these products were granted Notices of Compliance:

There is no evidence to indicate that Health Canada did not, in fact, approve the

four TMJ devices. The only evidence indicates that these devices were approved

on September 2, 1988….³⁹⁹

[356] This is untenable. The evidence is that on September 2, 1988 the letter was written

explaining why implants of this type would not be granted Notices of Compliance. This was

preceded by the letter of July 7, 1988 from W. J. Welsh to Gene L. Fagelson indicating that

safety and efficacy data would be required if Notices of Compliance were to be issued. The fact

is that no Notice of Compliance was ever produced. The Plaintiff’s position might have been

sustained if her counsel could explain why the letter of September 2, 1988 is wrong and why,

given the approval they maintain took place, there was no Notice of Compliance issued. The note

prepared by Lindsay Blaney is wrong. It depends on the database which, for whatever reason, is

wrong and is the source of the error. Lindsay Blaney said it was wrong although she, herself, was

unable to say how the error came about.⁴⁰⁰The four temporomandibular implants (and the

groupings they represent) were not given Notices of Compliance. The better question is whether

there was any possibility the note and its content or the database could have been released, made

public or, in some other fashion become known such that interested health professionals or the

patients they treat could have or did rely on the error the two documents contain. The note was

internal to the Health Protection Branch and, as the paragraph from the Submissions of the

Plaintiff quoted above notes, “no one outside the Pre-Market section had access to the database”.

[357] As for the Information Letter, Louis Boulay, who had from time to time filled in for

Nirmala Chopra and subsequently replaced her as Head, Premarket Review testified that the

purpose of providing this information was strictly commercial. The Medical Devices Bureau

would frequently receive telephone calls from manufacturers and distributors seeking

³⁹⁸Exhibit 71 T. 18

³⁹⁹Submissions of the Plaintiff at para. 375

⁴⁰⁰Transcript of Lindsay Blaney (September 20, 2019) at p. 61

Page: 121

information regarding which of their competitors’ devices had received Notices of Compliance.

The Information Letter was intended to provide this information directly to the industry such that

manufacturers and distributors would know what devices their competitors could sell and

advertise.⁴⁰¹In light of this purpose, the Information Letter was distributed only to manufacturers

and distributors of medical devices.⁴⁰²It was not intended for and was not delivered to health

professionals or patients:

No, it was not the target. If a letter was intended for a group of doctor[s] we had

another type — instead of information it's a "dear doctor" letter, and then it

contains some relevant clinical data that would be of interest to them. This is for

a doctor very dry reading, so that's — unless it's some clinical interest, quite often

they would not even read that, so there's "dear doctor" letter or there's "dear

petitioner" letter, I think there's different types of communication tools. This one

was just information to the distribution list we have there. So there was other

types of letters for other groups.⁴⁰³

[358] It was sent to those who had a commercial interest:

Often competitors wanted to know what the competition had on the market. We

did get many phone calls when something showed up on the market, did they get

approval last week or not, and then — so the target was, as pointed out in the top

of the letter, manufacturers and distributors.⁴⁰⁴

[359] There was no evidence from any doctor, or for that matter any patient, that he or she read

this Information Letter or relied on it to come to an understanding that the four devices it refers

to had received Notices of Compliance and based on that reliance implanted a patient with any

one of them. The representative plaintiff was unaware of the document’s existence as of late

2017, nearly 30 years after its publication and 18 years after the commencement of this

litigation.⁴⁰⁵There was no evidence that any person in Canada was ever implanted with one of

the Vitek Proplast TMJ implants erroneously listed in Information Letter 765, at any time, after

its publication in August 1989.

[360] Quite apart from the understanding that the four Vitek Proplast TMJ implants did not

receive Notices of Compliance is the fact that, as noted in the Submissions of the Defendant, the

Plaintiff, unlike the position now taken on her behalf, pleaded in her Second Fresh Statement of

Claim (April 28, 2014) that no Notice of Compliance had been issued in respect of the four Vitek

Proplast TMJ Implant noted in the Information Letter as having been granted them:

⁴⁰¹Transcript of Louis Boulay (June 11, 2019) at p. 62-63

⁴⁰²Ibid at p. 63 to 68

⁴⁰³Ibid at p. 64

⁴⁰⁴Ibid at p. 62

⁴⁰⁵Exhibit 72, T. B pp. 213-214

Page: 122

Health Canada staff recorded in Health Canada computer [sic] that Notices of

Compliance were issued for Vitek TMJ implants despite no such Notice of

Compliance having been issued.

…

Staff of the Clinical Assessment Division of Health Canada failed to report to the

Field Operations Division of Health Canada that Vitek TMJ implants were being

advertised for sale in Canada by Vitek and Instrumentarium in Canadian and

American publications and journals directed at the medical and dental

professions, despite the fact that these devices had not received Notices of

Compliance, staff in the Field Operations Division of Health Canada failed to

follow up on such reports.⁴⁰⁶

[361] The Statement of Claim, as quoted, is the form that is current and was relied on at trial. It

came after the decision of the Court of Appeal that determined, based on the pleading, then, in

place, that it was not plain and obvious that the Plaintiff could not succeed; that is that it was not

plain and obvious that Health and Welfare Canada could not be found to owe the Plaintiff a

private law duty of care. The allegation that these devices were misrepresented by Health and

Welfare Canada as having been granted Notices of Compliance when they had not was the

foundation on which this action was allowed to proceed:

The sustainability of Ms. Taylor's claim at this stage of the proceedings depends

primarily on the allegations of Health Canada's misrepresentations as to the status

of the Vitek implants between 1988 and 1990 and its failure to correct those

misrepresentations in the following years during which the implants were sold

into Canada without proper authorization and the evidence of the danger posed by

those implants continued to mount. Those allegations can be summarized as

follows:

…

- sometime in 1988, Health Canada wrongly represented in its database that

it had issued a notice of compliance referable to the Vitek implants;

- at various times in 1989, Health Canada, through its officials, repeated the

misrepresentation concerning the status of the Vitek implants and

indicated that Vitek had filed data establishing the safety of the implants to

Health Canada's satisfaction;

- in 1990, Health Canada discovered that it had wrongly represented that the

Vitek implants had received a notice of compliance, but it took no steps to

advise users or potential users of the implants or their health care

professionals of Health Canada's misrepresentation;

⁴⁰⁶Second Fresh Statement of Claim paras. 143(k) and 143(l)

Page: 123

- to Health Canada's knowledge, Vitek continued to sell implants in Canada

between 1988 and 1990, without the requisite notice of compliance…⁴⁰⁷

[362] This is important. The Crown not having understood the position of the Plaintiff to be

that, in fact, Notices of Compliance had been issued, was denied the ability to question any

witness, particularly those it called, as to this understanding of the circumstances. As an

example, the note written by Lindsay Blaney on November 9, 1994, the one saying that three

Vitek Proplast implants had received Notices of Compliance, arose from a conversation she had

with Francine Jacques (Gaudette) (see para [354] above). As such the evidence was hearsay. Had

the Crown been aware of the reliance on this memorandum and the conversation on which it is

founded counsel would have known to question Francine Jacques (Gaudette) about it. As it is,

she was not asked.

[363] I confirm the problem associated with the late adoption of this position by observing that

in the course of the opening statements counsel for the Plaintiff was clear that the position being

taken was that Information Letter 765 misrepresented the status of the four devices when it said

they were approved:

THE COURT: Oh. This is the thing [referring to Information Letter 765] that says

it’s been approved when it really hadn’t been? Is that what this is?

MR. LEGGE: That’s what I am saying.⁴⁰⁸

[364] Counsel went on to propose that the negligence that would be demonstrated, as the

evidence proceeded, was the failure to withdraw the statement that the devices in question had

received Notices of Compliance when they had not.⁴⁰⁹The same position was taken by counsel

on behalf the Ontario Health Insurance Plan which was separately represented as a result of its

subrogated interest in the return of payments it has made to members of the supposed class. It

moved through the trial, hand in hand with the Plaintiff. There was a lengthy exchange between

counsel and the Court in which counsel said that the representation in Information Letter 765 that

the four devices had Notices of Compliance when they did not had been relied on to the

detriment of members of the class.⁴¹⁰As already noted, as the case has developed, there was no

evidence that this was so.

THE INSPECTIONS

[365] The evidence of Francine Jacques contributes to an understanding of the circumstances

and context of the work being undertaken by those involved in the regulation of medical devices

during and around 1985 and beyond. Francine Jacques (Gaudette) testified using her married

name. In some of the material she is referred to as Francine Gaudette and to avoid any confusion

is referred to in these reasons as Francine Jacques (Gaudette). Like Pierre Blais, the reliability of

⁴⁰⁷Taylor v. Canada (Attorney General), supra (fn. 35) at para. 109

⁴⁰⁸Transcript of Opening Submissions (April 1, 2019) at p. 71

409

Ibid at pp. 73-74,

Ibid at pp. 75-81

410

Page: 124

the evidence of Francine Jacques (Gaudette) was questioned. She was produced by the Crown.

The concern was raised on behalf of the Plaintiff. She retired in 2008. This was after this action

had commenced but years before the trial. She was paid for her time. The Plaintiff says this

identifies her as an “interested witness” whose testimony should be evaluated from that

perspective. In making this submission, counsel for the Plaintiff relied on three cases. None of

them provide any definition of what demonstrates that a witness is “interested”. Presumably this

refers to an interest in the outcome of the trial: in the damages that may result, a particular

relationship with the individual or corporation which may receive or have to pay them or, in a

criminal proceeding, in the finding of guilt or not. Here the idea is that a witness who returns to

the service of her employer to work on a trial and is paid for that service should be accepted as

“interested”. It is difficult to see why this would not apply to any witness who is paid. The

proposition is that the bias and perspective of such a witness should be taken as purchased. This

can happen but it has to be demonstrated by more than the presence of payment. Generally, this

occurs when the witness is perceived by the Court as having become an advocate for a given

position rather than as a dispassionate observer. That is not the case here.

[366] Of the three cases referred to by the Plaintiff, two of them are criminal cases where the

accused had been charged with sexual assault. In R. v. M. G.⁴¹¹it was the credibility of the

complainant that was at issue. As the complainant, the witness’s “interest” in the outcome is not

hard to see. As it is, although the words “interested witness” are used in one of the quotations

(from another case) referred to in the judgment, those words were not associated with the

complainant. The reasons refer to her as a “crucial witness” which is the better description.

Otherwise every witness who has a view of what took place, or was involved in some way, could

be said to be “interested”. The second case is R. v. Kiss.⁴¹²This was the proverbial “he said, she

said” case. Whose story was to be believed: the accused or the complainant? Again, without

reference to the term “interested witness” in conjunction with the case itself, it seems that the

concern, if it is to be applied, was to the complainant who was believed. The account of the

complainant was “a central theme in this case”. The trial judge’s treatment of this evidence was a

ground of appeal. It was rejected. He found the complainant’s story “plausible i.e., in harmony

with the way things can and do happen”. The Court of Appeal found this “appropriate”. The

appeal from conviction was granted because of the failure of the trial judge to examine a

particular piece of evidence (the shirt the complainant was wearing at the time of the alleged

assault), because of the misuse of evidence called in reply and because of the trial judge’s

“uneven scrutiny” of the competing evidence.

[367] The third case relied on by the Plaintiff is Faryna v. Chorny.⁴¹³The appellant wrote a

letter questioning the chastity of the respondent. The witness to whom the letter was written left

it where the plaintiff discovered it. The law suit was for libel. The plaintiff was successful.

Among the questions on the appeal was the treatment of the evidence of the recipient of the

letter. Should the judge’s “interlocutory remarks” made during the trial be taken as findings as to

⁴¹¹1994 CanLII 8733 (ON CA), 73 OAC 356, 93 CCC (3d) 347, 24 WCB (2d) 643, [1994] CarswellOnt 181,

[1994] OJ No 2086 (QL)

⁴¹²2018 ONCA 184 (CanLII),

⁴¹³[1951] B.C.J. No. 152, [1952] 2 D.L.R. 354, 1951 CarswellBC 133

Page: 125

the reliability of that evidence and is it proper that a finding of credibility depend solely on

which person the trial judge thinks made the better appearance of sincerity in the witness box?

The answer to the first proposition is “no”. Such remarks are commonly made as part of the

judge’s inquiry and not demonstrative of any determination. The answer to the second question

is also “no”; the demeanour of the witness is not enough. This is the point that both R. v. M.G.

and R. v. Kiss extract from Faryna v. Chorny. Each contains the following quotation, as do the

Submissions of the Plaintiff:

The credibility of interested witnesses, particularly in cases of conflict of

evidence, cannot be gauged solely by the test of whether the personal demeanour

of the particular witness carried conviction of the truth. The test must reasonably

subject his story to an examination of its consistency with the probabilities that

surround the currently existing conditions. In short, the real test of the truth of the

story of a witness in such cases must be its harmony with the preponderance of

probabilities which a practical and informed person would readily recognize as

reasonable in that place and in those conditions.⁴¹⁴

[368] If this is what is said to distinguish the treatment of “interested witnesses” from others,

time has passed it by. Faryna v. Chorny was decided in 1951. What was said in that case may

have been new at the time; it is not today. For the most part, courts have learned that demeanour,

taken on its own is not a reliable way of assessing the credibility of any witness. It is recognized

that those who lie out of habit, or are pathologically inclined to do so may, through a confident

and forthright appearance, be taken as truthful. On the other hand, those unfamiliar with the

formality of a court room, in their anxiety to comply with the obligation to be truthful, may seem

nervous and uncertain and, based on demeanour alone, taken to be other than credible. As is said

in Faryna v. Chorny the circumstances, conditions, consistency or lack of it with other evidence

should be included as part of the analysis.

[369] The Plaintiff says there are inconsistencies in the evidence of Francine Jacques

(Gaudette) that should (along with the fact that she was paid) lead the Court to find her evidence

is not credible and make findings that contradict it. I reject this submission. The examples given

suggest she has:



recognized the continuing failure of the company to comply with the requirements

of the Medical Devices Regulations respecting the permission to sell and

distribute such devices, the implication being that a more forceful form of

enforcement should have been employed;⁴¹⁵



understood that devices, without the requisite permissions were being directly

imported by doctors (referred to as “private importation”) thus putting patients in

Canada at risk;⁴¹⁶and

⁴¹⁴Ibid at para. 11, R. v. M. G. supra (fn. 411) at para. 32 and R. v. Kiss, supra (fn. 412), at para. 30

⁴¹⁵Submissions of the Plaintiff at paras. 436-441

⁴¹⁶Ibid at paras. 442-443

Page: 126



realized that when she passed on the decision as to whether all doctors and

dentists, in Canada, should be notified as to the concerns with Vitek Proplast

implants to Health and Welfare Canada doctors and scientists, their decision was

not based on scientific or health-based considerations.⁴¹⁷

[370] Each of these issues is taken up in what follows. The overall context infiltrates each of

these discussions. Regardless of whether Francine Jacques (Gaudette) is an “interested witness”

the guidance provided by Faryna v. Chorny has been adhered to. The evidence has been

analysed, weighed and considered in the findings made. For the moment I point out that, as will

become clear:



in respect of the failure to impose stronger enforcement, I note that the regulatory

scheme was new and a policy determination made that it was better to work with

the companies involved, to educate and instruct, hopefully, to the benefit of those

who would be assisted by devices brought properly to market;



in regard to “private importation”, it is not certain there was any and if there was,

the numbers are small; and

concerning the notification of physicians and surgeons, Francine Jacques

(Gaudette) passed these decisions on to those responsible for making them; there

was a broader context to be considered.

[371] I find that Francine Jacques (Gaudette) was not an “interested witness”. There is nothing

in what she said that suggests a bias, a particular perspective on how these events should be

understood or their legal impact determined. Being paid for her time is not enough. Uncertainties

or supposed conflicts are not necessarily, and in this case are not, demonstrative of a witness

being an “interested” one. The demeanour of Francine Jacques (Gaudette) was in no sense

determinative of the weight, import or credibility given to her evidence but in the circumstances,

I take the time to observe that she was forthright, did her best to be complete and showed as a

committed servant to her responsibilities and understanding.

[372] Francine Jacques (Gaudette) had a long history of employment with Health and Welfare

Canada. She began her employment with the Québec region in 1973. At that time, she was

trained as a food and drug inspector. She was required to have, and had, a degree in science, in

her case in organic chemistry. With two breaks, one from 1978 until 1981 when she was rehired

and another from 1983 to 1985 when she returned from a maternity leave, she was employed by

Health and Welfare Canada until her retirement. In 1985, upon her return from maternity leave

she joined the medical devices unit. This was an important moment in the evolution of the

approach taken in the regulation of medical devices. It was shortly after the effective date of the

amendments to the regulation promulgated in 1983. As described by Francine Jacques

(Gaudette) the activities of the inspectors were becoming more proactive. They were initiating

interaction with corporations active in the industry. It was a period of education of those

⁴¹⁷Ibid at paras. 444-445

Page: 127

companies and rationalization of their operations in the context of the changed regulatory

scheme. When she joined the medical devices unit, in the spring of 1985, she, along with others

involved, as part of their education as to those changes, met with people associated with the

Environmental Health Directorate who were engaged in research and the evaluation of medical

devices. They met with workers at the Radiological Health Centre to learn what those workers

were doing and to establish relationships so that the help of those workers would be available, if

required. In November 1985 she organized a seminar to inform the industry and stakeholders

about the regulation of medical devices; 2000 people attended.⁴¹⁸

[373] As part of this process of education and rationalization, for the first time, a project

entitled “Inspection of Manufacturers, Importers, and Distributors of Medical Devices”, was

undertaken in which inspectors were sent to visit industry participants. The purpose was to assist

those companies in understanding the regulatory scheme, inspect their premises and evaluate

their processes with the purpose of encouraging voluntary compliance with the regulatory

scheme:

This project will provide for a nationwide opportunity to meet industry, to gather

information and data on several aspects of manufacturing and to determine the

need for enforcement action.

[374] The purpose was:

To contact and provide Canadian device manufacturers/importers/distributors

with the Health Protection Branch view of the current regulations, compliance

assistance and interpretation of the regulatory requirements relevant to their

industry.

To obtain information about manufacturing procedures, quality control methods

and distribution channels.

To assess Canadian Manufacturers/importers/distributors compliance with the

Medical Devices Regulations and to encourage voluntary compliance for

disclosed violations.⁴¹⁹

[375] In furtherance of this approach, Francine Jacques (Gaudette), on March 18, 1986, visited

Instrumentarium Inc. in Terrebonne, Québec. In preparation for the visit she reviewed the

regional file to learn about any previous visits that had taken place, any problems that had

appeared and whether the company had been cooperative. Had it taken action as requested?⁴²⁰

⁴¹⁸Transcript of Francine Jacques (June 17, 2019) at p. 5

⁴¹⁹Exhibit 59 at T. 11 (Device Manufacturing Practice Evaluation (March 1984) and Exhibit 61A T. 71 as well as

Agreed Statement of Facts at para. 88 itself footnoting AGC-08407. 004 apparently retitled as: Inspection of

Manufacturers, Importers and Distributors of Medical Devices (January 4, 1986)

⁴²⁰Transcript of Francine Jacques (June 17, 2019) at p. 20

Page: 128

[376] On December 20, 1985, that is prior to the inspection, the Québec Region of Health and

Welfare Canada’s Field Operations Directorate (“FOD”) provided the Secretary-Treasurer of

Instrumentarium Inc. with copies of the 1978 codification of the Medical Devices Regulations

and extracts from the Food and Drugs Act applicable to medical devices, a guide on device

labelling, a brochure on medical instruments, a copy of Information Letters dealing with new

devices and clinical trials, and a guide on preparing submissions under Part V of the Medical

Devices Regulations.⁴²¹This was an initial step in the effort to educate this member of the

medical devices industry.

[377] The inspection of March 18, 1986 was conducted in the context of the “project” the stated

purposes of which are quoted above. During the course of the visit, Francine Jacques (Gaudette)

filled out a reporting form⁴²²; it was subsequently typed.⁴²³There was a second page or version

of this form,⁴²⁴also later converted to type.⁴²⁵The report includes an appendix 3: “Investigative

Report”.⁴²⁶It too was later typed.⁴²⁷The report was followed by a letter, dated April 1, 1986,

from Francine Jacques (Gaudette) to Michelle Laferrierre Lemieux, Secretary-Treasurer of the

company.⁴²⁸Under the heading “General Remarks” the report notes, among other things:

In operation since 1977, this firm has never issued a device notification. More

than 70 manufacturers are supplying it with products and approximately 20 of

them have completed declarations naming the firm as a distributor for more than

3000 products.

…

Ms. Lemieux [the Secretary-Treasurer] did not appear to be very well-informed

about our legislation. Her initial contact with us was not until December 1985.⁴²⁹

[378] The appendix underscores the concern with the company’s failure to properly provide

notification of devices it intended to market:

Device notification

The firm has not completed any declaration since its beginning in 1977. However,

24 of its 71 suppliers have, and they have named the firm as a distributor.

⁴²¹Agreed Statement of Facts at para. 87 itself footnoting the letter enclosing the listed material. The Agreed

Statement of Facts shows the letter as having been dated December 10, 1985. The letter, itself, is dated December 20

1985. I have used the date from the letter.

⁴²²Exhibit 59 at T. 4

⁴²³Ibid at T. 16

⁴²⁴Ibid at T. 72

⁴²⁵Ibid at T. 16 and 72

⁴²⁶Ibid at T. 4

⁴²⁷Ibid at T. 72

⁴²⁸Ibid at T. 17

⁴²⁹Ibid at T. 16 (On what I have referred to above as the second page or version)

Page: 129

[379] The appendix goes further. It expresses a concern in respect of those products to which

Part V applied; that is those requiring a Notice of Compliance:

New devices/notice of compliance

The firm has been selling a few implants for a number of years, including Proplast

prosthetic devices (Vitec) [sic] and Allen ophthalmic implants (Precision-

Cormet). Since April 1983, only one implant has been marketed, namely Cotrel

rods (1984). Instrumentarium has sent French manufacturer Sofamor all the

documentation on applying for a notice of compliance for the project. There were

no Cotrel rods in stock.

[380] The report, in company with the appendix, outlines three concerns derived from the

inspection:



The Secretary-Treasurer of the company did not have a proper understanding of

the regulatory regime. This was partly explained by the death of her husband who,

it seems, had been the directing mind of the company. Michelle Laferrierre

Lemieux had only recently taken over. She had been a nurse.⁴³⁰

The difficulty with the notification of the products being sold was explained by

Francine Jacques (Gaudette). The notification requirement applied to

manufacturers. As noted in the quotation above, from the appendix, of the 71

suppliers to Instrumentarium Inc. 24 had complied with this requirement.

There were Proplast implants on site. They had been sold through Intrumentarium

Inc. since the 1970’s. There is nothing to suggest those seen, during her

inspection, by Francine Jacques (Gaudette), were temporomandibular joint

implants. To the contrary her recollection was of “a dimple chin implant”⁴³¹

which would be cosmetic and not orthopaedic. Of greater concern were the

“Cotrel rods” which Instrumentarium Inc. offered for sale. These are the implants

used to treat teenagers with curvature of the spine.⁴³²There were none in stock⁴³³

but they had been the subject of a telephone call from Michelle Laferrierre

Lemieux to Health and Welfare Canada inquiring as to the applicable regulations

governing their sale.⁴³⁴They were subject to the requirements of Part V of the

Medical Devices Regulations. They had to have a Notice of Compliance.⁴³⁵

[381] The letter of April 1, 1986, that followed up on the inspection dealt with the issues of

concern, in particular “Device notification” and “New device[s]”:

⁴³⁰Transcript of Francine Jacques (June 17, 2019) at p. 37

⁴³¹Ibid at p. 52

⁴³²Ibid at p. 80

⁴³³Ibid at p. 68 and p. 79

⁴³⁴Ibid at pp. 38-39

⁴³⁵Ibid at p. 39 and p. 79

Page: 130

Device notification

A notification has not been provided for every device you are selling, as

required under section 24 of the Medical Devices Regulations, within 10 days

from the day of which each device was first sold.

[382] The letter does not stop there; it provides further information and instruction as to how

the company should proceed:

Enclosed is a computer printout of the suppliers that have fulfilled this

requirement and named you as a distributor:

As for your other suppliers, you must contact them as soon as possible and ask

them either to authorize you to complete the declaration or to complete the

declarations themselves.

[383] The letter goes further. It offers the assistance in complying with the regulations:

Gilles Latulippe, who heads the declarations section of the Bureau of Medical

Devices, Ottawa, [telephone number provided], would be pleased to assist you

should you encounter any problems in complying with the regulations.

[384] It appears that Michelle Laferrierre Lemieux (referred to as Michelle Laferrierre) took up

the offer. Gilles Latulippe wrote to her, on April 21, 1986, in response to a letter he had received

from her dated April 15, 1986.⁴³⁶On May 1, 1986, Gilles Latulippe wrote to Vitek Inc. to inform

that Health and Welfare Canada had reason to believe that Vitek Inc. was advertising medical

devices in Canada. Gilles Latulippe went on to advise Vitek Inc. of the notification requirements

prescribed by the Medical Devices Regulation. He sent a copy to Michelle Laferrierre

Lemieux.⁴³⁷Gilles Latulippe went further. He undertook to contact each of the suppliers of

Instrumentarium Inc. to ask them to either complete the notification form or to authorize

Instrumentarium Inc. to do this on their own behalf.⁴³⁸

[385] In respect of “New device[s]” the letter of April 1, 1986 states:

New device

Section 33 of the Regulations prohibits the sale of a new device without a notice

of compliance. The sale of Cotrel Rod implants is therefore not permitted until the

manufacturer obtains a notice of compliance for it (section 34). Needless to say,

this applies to any implant from a given manufacturer marketed in Canada as of

April 1983.

⁴³⁶Exhibit 61A T. 15 and Exhibit 59 T. 20

⁴³⁷Agreed Statement of Facts at para. 90; Exhibit 59 T. 21

⁴³⁸Transcript of Francine Jacques (June 17, 2019) at p. 107; Exhibit 59 (Medical Device Plant Inspection Report,

Appendix 3)

Page: 131

[386] Francine Jacques (Gaudette) explained that Intrumentarium Inc., was not unique. It was a

common occurrence that distributors were selling medical devices in circumstances where the

manufacturer had not provided the required notification. The responsibility to give notice lay

with the manufacturer – not the Canadian distributors unless they had written authority from the

manufacturer. The vast majority of devices (95%) sold by Canadian distributors were

manufactured outside of Canada, and it was difficult for Canadian distributors to comply with

the notification requirement since they would need the cooperation of the foreign

manufacturer.⁴³⁹

[387] At a time shortly after her visit to Instumentarium Inc., as a result of looking at custom

manifests, Francine Jacques (Gaudette) became aware that the company was receiving Cotrel

rods. Francine Jacques (Gaudette) wished to ensure that the product was not being sold. She

sought advice as to whether or not a Notice of Compliance had been issued. It had not. As part of

her inquiry, Francine Jacques (Gaudette) called Pierre Blais. She wanted to know more about

Cotrel rods. What were they used for? Did he know anything about that? On June 3, 1986, she

returned to Instrumentarium Inc. Francine Jacques (Gaudette) found that there were 81 Cotrel

rods in stock. She advised Instrumentarium Inc. that the sale of the product would constitute a

violation of the Medical Devices Regulations. Despite considerable pressure from surgeons, the

company respected the regulatory scheme and did not sell the Cotrel rods.⁴⁴⁰Francine Jacques

(Gaudette) testified that a submission was made requesting a Notice of Compliance for the Cotrel

rods. There were surgeons who wanted them to be available to assist their patients. At first the

submission was rejected. The information provided was insufficient, some was missing. Francine

Jacques (Gaudette) was directed to place Intrumentarium Inc.’s stock of Cotrel rods under

voluntary detention.⁴⁴¹The problem was overcome and a Notice of Compliance was issued

during November 1986.⁴⁴²At that point, Intrumentarium Inc. was free to sell Cotrel rods.⁴⁴³

[388] In the final Submissions of the Plaintiff counsel finds fault with Health and Welfare

Canada in that on discovering Instrumentarium Inc. was selling Cotrel rods without notification

or a Notice of Compliance, no “prompt review of the company’s stock for additional non-

compliant devices pursuant to the regulatory powers available to Ms. Jacques and her

colleagues” was undertaken.⁴⁴⁴To counsel: “It is unclear why such regulatory actions provided

for by statute did not take place against Instrumentarium after her 1986 inspection.”⁴⁴⁵

[Emphasis added] I find the use of the word “against” instructive. This is not a circumstance

where the regulator stands in opposition to the manufacturer. Here, there was the introduction of

a significant change to the regulatory scheme. Health and Welfare Canada chose to follow the

general instruction and policy directed to helping companies understand their responsibilities and

guide them to compliance. There is nothing inherently wrong with this. With assistance, a Notice

of Compliance was forthcoming, and surgeons were able to use Cotrel rods to the betterment of

⁴³⁹Ibid at pp. 61-65

⁴⁴⁰Ibid at pp. 81-87 and Exhibit 59 at T. 22 and T. 23

⁴⁴¹Ibid at p. 88

⁴⁴²Ibid at pp. 87-89

⁴⁴³Exhibit 59, T. 35

⁴⁴⁴Submissions of the Plaintiff at para. 309

⁴⁴⁵Ibid at para. 307

Page: 132

their patients. This is consistent with the collaborative approach referred to by Janice Hopkins

and approved as policy.

[389] The inspection did reveal that Proplast products, albeit chin and not temporomandibular

joint implants, were “in stock” at Instrumentarium Inc. There was follow up through the letter of

April 1, 1986, which provided instruction on how to proceed and offered assistance through

Gilles Latulippe who wrote directly to Vitek Inc. to advise of the concern and the regulatory

requirements.⁴⁴⁶

[390] Over the next three years Francine Jacques (Gaudette) continued to interact with

Instrumentarium Inc. She summarized those activities:

I don’t recall meeting there, but there were phone calls - phone enquiries,

because at times I would look at custom manifests that would come in, and if I

would see something that I don't know, is this a Part V or not, I would call them

to ask, what is this used for, how long does it stay in the body. I would call —

sometimes — I did call Dr. Blais on one occasion, asking him, do you know what

is the usage of that, was trying to ascertain that products coming in, could there be

new implants if they are coming in. I was, like, overlooking, like that. I had

contact with the company, phone calls, but there was no complaint that we had

received, no investigation on-site, no — that I am aware of in the three-year

period before I go back in 1989.⁴⁴⁷

[391] There was a second occasion when Francine Jacques (Gaudette) visited and inspected the

premises at Instumentarium Inc. This happened in 1989. The inspection program pursuant to

which the 1986 inspection had taken place continued. Each year the description was redrafted.

The 1988 version, still entitled “Inspection of Manufacturers, Importers, and Distributors of

Medical Devices”, remained in effect at the time Francine Jacques (Gaudette) visited

Instrumentarium Inc. during April 1989. The three statements of purpose quoted above (see:

para. [374 ] above), now called “Goals” remain essentially unchanged. A new “Goal” was

included:

To encourage the Canadian industry to use good manufacturing practices (GMP)

and use the FDA approach as recognized guidelines in this area.

[392] By 1989 the inspectors were better equipped and more experienced in carrying out these

inspections:

There is more information on how to do the inspection. We were now linked

electronically with the Bureau of Medical Device. We had access to notification,

⁴⁴⁶Exhibit 59 T. 21

⁴⁴⁷Transcript of Francine Jacques (June 17, 2019) at p. 90

Page: 133

to the problem reports. We were better equipped. We were equipped with

computers, and we were better equipped. ⁴⁴⁸

[393] Francine Jacques (Gaudette) advised the Court that it had been established that there

should be a follow up visit “at three years afterwards”. ⁴⁴⁹The April 1989 inspection, following

up on the March, 1986 visit was consistent with that direction.

[394] As in 1986, Francine Jacques (Gaudette) prepared for the inspection that took place in

April 1989. She looked at what she had done before. The experience with Cotrel rods had alerted

her to concerns about Intrumentarium Inc.’s understanding of how Part V “New devices” were to

be dealt with. She knew Instrumentarium Inc. was selling Vitek Inc. products that had been the

subject of submissions directed to obtaining Notices of Compliance. She obtained a printout with

all the Notices of Compliance issued and the submission numbers of those that were rejected and

those for which more information had been required.⁴⁵⁰There were 100 files for Vitek Inc.

products.⁴⁵¹Through the review of customs manifests she recognized that there were Vitek Inc.

devices coming through that she was not familiar with.⁴⁵²

[395] Francine Jacques (Gaudette) also looked at the state of notifications sought by suppliers

with respect to products being distributed by Instrumentarium Inc.:

And this is where I've seen that there were now more suppliers that have filed

notification, because in the — that's what I was trying to explain, that there were

many suppliers that had indicated that Instrumentarium was distributing their

numerous products. There were more than 6,000 products notified from

something like 38 suppliers….⁴⁵³

[396] Francine Jacques (Gaudette) prepared a report of her inspection of April 4, 1989. In

respect of those devices requiring only notification, in the course of giving evidence, she said

(this is the continuation of the quotation immediately above):

… but still, when I went to the company, they were still making business with

71 suppliers, 70, 71. I would like to see the figures. And it was still — still not

in compliance, not in total compliance. There were improvement[s] in the three

years, but they were still uncompliant with notification.⁴⁵⁴

[397] In the report she noted:

Device notifications

⁴⁴⁸Ibid at p. 91

⁴⁴⁹Ibid at p. 96

⁴⁵⁰Ibid at p. 94 and 97-98 and Exhibit 12 T. 19 also at Exhibit 59 T. 39

⁴⁵¹Ibid at p. 97

⁴⁵²Ibid at p. 98 and 101

⁴⁵³Ibid at at p. 102 and p. 104-105 where relying on her handwritten notes made at the time of her 1989 inspection

Francine Jacques testified that there were 6,800 products for which notification had been received (Exhibit 59 T. 8).

⁴⁵⁴Ibid at (June 17, 2019) at p. 98

Page: 134

Device notifications are out of date. Only 20 of 70 suppliers have declared their

products. Following the inspection in 1986, Instrumentarium contacted Gilles

Latulippe. He agreed to contact all of Instrumentarium’s suppliers. The firm has

taken no other action since then.⁴⁵⁵

[398] Consistent with the understanding that “…voluntary compliance for disclosed violations

is the preferred route.”⁴⁵⁶The report goes on to suggest how this deficiency should be dealt with:

I suggested first contacting all suppliers not in compliance with section 24 to

obtain their authorization to produce declarations and then, once the

authorizations have been obtained, sending them to Gilles Latulippe with a

computer listing of the most commonly sold products (6,000 at the time of our

visit).

[399] Ultimately the question of how to deal with any deficiency of the notification

requirements (by further encouragement or enforcement action) is a matter of discretion left to

the inspector and those responsible for overseeing compliance with the regulation:

General

Though voluntary compliance is preferred, the procedure described below should

be followed in the case of uncovering violations. Where follow-up of violation

indicates that encouraged voluntary compliance did not occur, the available

⁴⁵⁵Exhibit 59 at T. 40

⁴⁵⁶Ibid at T. 38 The full statement of the paragraph in which the quotation appears states (para. 3.4):

Though voluntary compliance for disclosed violations is the preferred route, inspector will

initiate enforcement action where indicated and called for in the Procedure to this project under

item 5.5 entitled Compliance/Enforcement activities.

Paragraph 5.5 referred to states:

Exit Interview

During the exit interview, the inspector will draw management’s attention to violations. He will

also confirm these violations in writing and ensure that appropriate follow-up is initiated. Refer

to section 5.6 for information.

That section (5.6) states:

Compliance/Enforcement Activities

The inspector will assess compliance with sections of the regulations outlined in 3.4.

In all cases his assessment is based on the evaluation of a manageable sample of devices selected

among the highest risk type ones which are offered for sale by that company.

Page: 135

information should be reviewed jointly with the responsible officer in the

Operation and Compliance Division (J. Moore). Factors including the nature of

the enforcement action to be initiated are, for example:

- regulatory requirement(s),

- resources available to initiate enforcement action,

- nature of the health risk vs technical violation,

- population at risk,

- magnitude of public and professional concerns,

- user qualifications,

- potential effectiveness of regulatory action.⁴⁵⁷

[400] It was open to the Health Protection Branch to opt for the continued encouragement of

voluntary compliance and stands as an appropriate, reasonable and responsible exercise of that

discretion. The collaborative approach continued. Although not fully compliant, there had been

improvements. After her second inspection, as with the first, on April 12, 1989, Francine Jacques

(Gaudette) wrote a letter to Michele Laferriere Lemieux (now recognized as the President of

Instrumentarium Inc.) following up on what she had found. In line with her report and the

continuing effort to push Instrumentarium Inc. to comply with the regulation she wrote:

Section 24-Device notification

A notification has not been provided for every device that you are selling. Only

approximately 20 of your 70 or so suppliers appear in our databank.

Some suppliers in the databank are no longer doing business with you, and others

have never done business with you.

Given your specific situation and the large number of products you are importing,

we recommended a way for you to comply with this requirement. Section 26

describes the way in which a manufacturer outside Canada may authorize an

importer to complete device notifications.

The section in charge of device notifications at the Bureau of Radiation and

Medical Devices processes data regarding declarations. The section is led by

Gilles Latulippe…

[phone number and address provided]

⁴⁵⁷Ibid at T. 38 (Inspection of the Manufacturers, Importers and Distributors of Medical Devices) at para. 5.6.1

Page: 136

Please inform us about the action you are taking to comply with this regulation.⁴⁵⁸

[401] In any case, for the purposes of this decision, the treatment of “Device notification” does

not matter. It was accepted and understood by all parties that the products of concern are all

subject to Part V of the Medical Devices Regulations. As such they required Notices of

Compliance, notification was not enough.

[402] The report prepared by Francine Jacques (Gaudette) following her second inspection

(April 1989) also considered the state of Instrumentarium Inc.’s compliance with Part V. The

report states:

⁴⁵⁸Ibid at T. 41

Page: 137

Test before sale

The firm is selling either very simple surgical devices or Part Vs that have

device notifications.

[403] Where the report form requires it, Francine Jacques (Gaudette) graded this aspect of

regulatory compliance (“Regulations concerning… (g) New device”) as an “A” which is said to

be “Generally satisfactory”. An “A” rating is also described as meaning:

…that no or only minor concerns are noted.⁴⁵⁹

[404] Francine Jacques (Gaudette) indicated that she was unaware that any Part V devices were

being sold without Notices of Compliance having been issued. She explained her understanding:

What happened is that I thought that that company, knowing our regulation,

having been providing submission, trying to comply with our regulation, Madame

Lemieux, having been cooperative in the case of the Cotrel rods, telling me

readily that this product was a Part V without the notice of compliance, I had no

idea that she would be selling knowingly a product without a notice of

compliance, and that printout from the Bureau of Medical Device was approved

[sic] for me that the company Vitek was getting — was complying with the

regulations and submitting the right information, so I gave them an A rating for

Part V products.⁴⁶⁰

[Emphasis added]

[405] She had the printout that showed as approved those implants that had not been.⁴⁶¹She

thought that they had been approved and governed herself on that understanding. The printout

was not a public document; it was internal to Health and Welfare Canada. As it is, Francine

Jacques (Gaudette) understood these temporomandibular joint implants to have been the subject

of Notices of Compliance. When she saw that they were being imported into Canada she

accepted this as a demonstration that Instrumentarium Inc., following its experience with Cotrel

rods, understood, accepted and had acted on its responsibility to obtain Notices of Compliance

for these devices.

[406] The Submissions of the Plaintiff draw attention to the importation of Proplast products

into Canada. The proposition appears to be that since Francine Jacques (Gaudette) had available

to her and reviewed medical device customs manifests for Instrumentarium Inc. and was aware

that the company was importing medical devices manufactured by Vitek Inc. she should have

stopped the importation of Vitek Proplast implants subsequently implanted into members of the

class:

⁴⁵⁹Ibid at T. 38 at para. 5.7

⁴⁶⁰Transcript of Francine Jacques (June 17, 2019) at p. 115 I believe the word “approved” beginning the last full

line of this quotation should be “proof”.

⁴⁶¹Exhibit 12 T. 19 also at Exhibit 59 T. 39

Page: 138

It is unclear how a proper review by Ms. Jacques in 1986 would not have

disclosed the multiple non-compliant importations of Vitek Proplast TMJ

implants inserted into members of the class including Judy Munro who testified at

trial.⁴⁶²

[407] This comment is directed to the 1986 inspection. I do not accept the proposition that

underlies this submission. The review undertaken by Francine Jacques (Gaudette) in 1986 was

not improper. It was consistent with the program purpose of encouraging voluntary compliance

with the regulatory scheme. It accounted for those devices requiring that notice be provided by

the manufacturer, pursuant to what was then Part II (s. 24) of the, then current, Medical Devices

Regulations, allowing for sale in Canada.⁴⁶³It accounted for “new devices”, those requiring

submissions and the issuance of a Notice of Compliance including those provided by Vitek Inc.

with follow-up instructions on how to proceed, and direct communication by Gilles Latulippe

with Vitek Inc. as the manufacturer and with each of the other suppliers of Instrumentarium Inc.

[408] During the 1989 inspection, Francine Jacques (Gaudette) proceeded on a false

understanding. She thought that the temporomandibular joint implants listed as accepted on the

printout had received Notices of Compliance. Given they had not, the unanswered question is,

had she been properly informed would she, or rather would a reasonable person with the

appropriate knowledge and experience have recognized that those “new devices” were being

imported without the requisite Notices of Compliance and, if so was there an obligation to act

and was the failure to do so a breach of any duty of care that was present? I shall return to this

later in these reasons.

[409] For the moment I note the following. The Medical Devices Regulations referred to the

importing of medical devices into Canada. The sections involved reflect on all medical devices

not just “new devices”, being the ones that require a Notice of Compliance. This part of the

regulation begins with a general prohibition:

16. Subject to section 20 [which has no relevance to this case], no person shall

import into Canada for sale a device the sale of which in Canada would constitute

a violation of the Act or these Regulations.

[410] This is followed by three sections which outline the related authority of an inspector:

17. An inspector may examine and take samples of any device sought to be

imported into Canada.

18. Where an inspector examines or takes a sample of a device pursuant to section

17, he may submit the device or sample to an analyst for analysis or examination.

19. Where an inspector, upon examination of a device or sample thereof or on

receipt of a report of an analyst of a result of an analysis or examination of the

⁴⁶²Submissions of the Plaintiff at para. 312

⁴⁶³Medical Devices Regulations s. 24(1):

Page: 139

device or sample, is of the opinion that the sale of the device in Canada would

constitute a violation of the Act or these Regulations, the inspector shall so notify

in writing the collector of customs concerned and the importer.

[411] These sections have no value here. The concern is that the inspector (Francine Jacques

(Gaudette)) thought the devices in question had received Notices of Compliance. There was no

reason for her to take a sample or have an analyst look at one. These sections do not help

determine how the reasonable inspector would necessarily have responded, knowing the devices

had not received Notices of Compliance. There is discretion as to whether any device should be

stopped and analysed.

[412] Reference was made to a document entitled “Drug & Environmental Health Inspection

Division, Ontario, Region: Customs Surveillance Program.⁴⁶⁴The goals of the “Customs

Surveillance Program” are cited as:

1. Increase our visibility and emphasize our interest in the importation of foods, drugs and

devices to Customs Canada.

2. Encourage the provision of customs invoices of Customs Canada to HPB.

3. Monitor incoming customs invoices to identify firms who have not notified on drugs and

devices.

4. Encourage Appraisers to hold shipments for our examination if 4^thcopy of entry

document not available and to provide prompt response to requests for examination.

5. Improve our capability to refuse entry of violative commodities at the port of entry.

[413] These goals are directed to demonstrating interest, obtaining information and improving

the capability to refuse entry. It is not directed to ensuring that drugs and devices will always be

stopped or refused entry or to undertaking any legal responsibility when they are not held up at

the border. This is underscored by the outlined “Methods of Implementation”:

A.

A visitation program to the Ports of entry in the Toronto area on an 8-

week cycle. Frequency will be reassessed after implementation.

Through implementation we will:

1) Educate Customs Canada Staff to HPB needs

- providing awareness of what constitutes a Drug or Device

(Medical or Radiation Emitting Device).

⁴⁶⁴Exhibit 32 (Customs Surveillance Program)

Page: 140

- providing guidance on when a shipment should be detained for

HPB inspection.

2)

3)

Selectively examine or sample shipments being appraised (or

recently appraised) for review of label or other compliance issues.

Gain an appreciation of the difficulties encountered by various

ports of entry in fulfilling their obligations.

B.

Monitor incoming customs invoices covering devices (Medical &

Radiation Emitting Devices) and drugs to determine if notification

requirements have been met.

[414] There is no undertaking or commitment, within the program, to find and prohibit from

entry any device not subject to notification or a Notice of Compliance.

THE RECALL

[415] It is not that no effort was made to advise those involved and affected by the implantation

of Vitek Proplast implants. In 1990 there was a recall of interpositional implants (“IPI’s”). In

1994 it became apparent that the concern for the safety of these products had extended to cover

not only interpositional implants but also TMJ Fossa Prosthesis, Type VK and TMJ Condylar

Prosthesis, Type VK such that practitioners were advised to follow up with patients that had been

implanted with these devices.

[416] It bears repeating that none of these products had received a Notice of Compliance and

that any sales that had taken place were illegal in that the requisite acceptance by Health and

Welfare Canada was not in place. However, as observed by Francine Jacques (Gaudette) during

her inspections, a small number of interpositional Vitek implants had been sold through

Instrumentarium Inc., the only Canadian distributor.

[417] In Canada a recall of any medical device was defined and referred to in the Medical

Devices Regulations as they appeared and applied during the material time (1990-1991):

“recall” or “correction”, in respect of a device that has been sold, means any

action taken in respect of the device by that manufacturer or importer thereof after

becoming aware that the device:

(a) is or may be hazardous to health,

(b) fails or may fail to conform with any claims made by the manufacturer or

importer relating to the effectiveness, benefits, performance characteristics

or safety of the device, or

(c) does not comply with the Act or these Regulations,

Page: 141

to recall or correct the device or to notify the owner or user of the device of the

effectiveness thereof ⁴⁶⁵

[418] What is clear is that the primary responsibility for a recall lay with the manufacturer or

importer, in this case Instrumentarium Inc.⁴⁶⁶The role of Health and Welfare Canada was to

monitor the effectiveness of the firm’s recall actions. It did this through the Field Operations

Directorate which provided scientific, technical and operational advice.⁴⁶⁷

[419] The immediate catalyst for the recall that took place in 1990 was a “Voluntary Safety

Alert” issued by Vitek Inc. on March 23, 1990. The Vitek Voluntary Safety Alert was addressed

to “Dear Doctor” and among other things noted:

The purpose of this letter is to inform you of the following reported concerns

which affected the Vitek TMJ IPI. The corresponding catalogue numbers are

912.71, 912.72, 912.74, 912.76, 912.77 and 912.78.

…

Debris in the joint from alloplastic implants can contribute to progressive bone

degenerative changes and to giant cell reaction. All patients including

asymptomatic patients, should be monitored closely to assure proper patient

maintenance. This monitoring should include clinical and radioactive

examination.

…

⁴⁶⁵Consolidated Regulations of Canada (1978) Volume VIII, Ch 871, s. 2

⁴⁶⁶This is further confirmed by Part IV of the Regulations: "Recall or Correction of a Device". The applicable

sections each begin as follows:

s. 29 Every manufacturer and importer of a device that has been sold in Canada shall maintain

records of the following: …

[List of the required records]

s. 30 Every manufacturer and importer of a device that has been sold in Canada shall, on or

before initiating a recall or correction of the device, provides a director with the following

information:…

[List of the required Information]

s. 31 Every manufacturer and every importer of a device that has been sold in Canada and in

respect of which a recall or correction has been initiated shall notify the Director of the results of

the recall or correction as soon as those results become known to the manufacturer or importer.

⁴⁶⁷Exhibit 60 at T. 1 (Information Letter 661)

Page: 142

… it is strongly recommended that these patients be followed indefinitely. Please

inform all your patients who have received a Vitek IPI of the importance of

follow-up.

The prophylactic removal of Vitek’s IPI is not recommended.

…

Additionally, do not implant any more of these devices if you have any of them in

your possession. These implants should be returned for credit.⁴⁶⁸

[420] Health and Welfare Canada was aware of this “firm-initiated recall…by May 16,

1990”⁴⁶⁹. On May 17, 1990, Health and Welfare Canada sent an Information on Potential Recall

to the Medical Device Unit in the Central Region, detailing that “IPI’s may fragment, delaminate

or otherwise be damaged or punctured. Debris in joint from implants can contribute to

progressive bone degenerative change and giant cell reaction.”⁴⁷⁰By August 3, 1990, Health and

Welfare Canada learned that four doctors in Canada had received implants.⁴⁷¹On August 14,

1990, a list of Vitek Inc. products with and without Notices of Compliance was delivered to the

Operations Division by the Premarket Review Section.⁴⁷²On August 20, 1990, Instrumentarium

Inc. issued a Product Recall, sending the Voluntary Safety Alert letter requesting immediate

recall of all lots of catalogue no’s: 912.71, 912.72, 912.74, 912.76, 912.77, and 912.78 (the

Interpositional Implants). The Product Recall was addressed to “All Instrumentarium Agents”

(there were five of them) and provided these instructions:

Please read the letter carefully and make sure that every physician having used

these items are made aware of the situation. Also included you will find a list of

your hospitals who have purchased any of these items, the quantity purchased and

⁴⁶⁸Exhibit 70 at T. 2 and Exhibit 58 T. 3

⁴⁶⁹Agreed Statement of Facts at para. 113

⁴⁷⁰Ibid at para. 114

⁴⁷¹Ibid at para. 115 and see Exhibit 49 T. 11. The document states:

According to a FDA listing of distributors and oral surgeons received from Operations and

Compliance Division, the distributor for Vitek products in Canada is Instrumentarium,

Terrebonne, Quebec. Only four of the listed oral surgeons on the list in Manitoba were able to be

contacted. None of them had heard of the recall or had received the letter. Three of the doctors

had not implanted any of the devices and the other had implanted two of them. He indicated that

no problems had occurred with the device. He had obtained the implants from Instrumentarium.

Nonetheless, paragraph 115 of the Agreed Statement of Facts says that by August 3, 1990 Health and Welfare

Canada had learned that four doctors in Canada had received implants. This is as agreed to by the parties. What I

take from this is that upon investigation not many doctors in Canada had purchased and implanted Vitek TMJ Inter-

Positional implants. As part of the recall, it was determined that, as of August 28, 1990, Instrumentarium Inc. had

imported 207 Vitek IPI Implants of which it retained 8, leaving 199 that had been sold, 37 of which were recovered

as part of the recall indicating that possibly 162 had been implanted (see: Exhibit 70 T. 3 and Exhibit 59 T. 52 and

for the English Translation also see: Exhibit 59 T. 52)

⁴⁷²Exhibit 56 T. 16

Page: 143

the period of the purchase. We suggest that you leave a copy of the notification

letter behind with each of the physicians involved.

[421] Instrumentarium Inc. asked that products be returned within 48 hours.⁴⁷³

[422] Enclosed with the instruction was a list of the doctors and hospitals that had purchased

the implants that were of concern at the time, the number purchased by each of the recipients and

the date of those purchases. The instruction was that each and every one of the purchasers of the

Vitek Interpositional Implants was to be contacted. There is an inconsistency that was not

accounted for. The list that accompanies the instruction refers to 183 implants. Francine Jacques

(Gaudette), during the course of her inspections, found that 199 had been sold.⁴⁷⁴As it is, more

effort than these instructions suggest was made to notify those who had purchased, implanted or

been the recipient of one these implants.

[423] On August 21, 1990, further to the recall, Francine Jacques (Gaudette) visited

Instrumentarium Inc. On her arrival Francine Jacques (Gaudette) was advised that the company

had already instructed their representatives to visit each customer and take any product left and

to inform the physicians of the follow-up that was to be undertaken.⁴⁷⁵Francine Jacques

(Gaudette) did not limit the scope of her visit to Vitek Proplast-Teflon IPI’s. These were the

devices that had been the subject of the recall. She examined all Vitek products on site. She

detained all non-compliant devices, including eight Vitek Proplast-Teflon IPI’s:

…That listing was very important for me because it was decided that I would

evaluate all Vitek products on-site at Instrumentarium. And that enabled me to

know precisely which one had a notice of compliance that had been agreed to, or

if there were products without a notice of compliance, I detained the products. So,

I didn’t ….Not only did I make a recall monitoring of the situation for the TMJ

IPI, but I also look[ed] at all of their inventory of Vitek products to verify if they

were in compliance with Part V requirements or not.⁴⁷⁶

[424] On August 23, 1990, in a letter to Instrumentarium Inc., the Québec Regional Office of

the Health Protection Branch, in the person of Francine Jacques (Gaudette), confirmed the recall

actions including the “voluntary detention” of all Vitek Proplast implants for which a Notice of

Compliance had not been issued.⁴⁷⁷On October 4, 1990, certain units were returned to

Instrumentarium Inc.⁴⁷⁸The chronologies reviewed during the cross-examination of Lindsay

⁴⁷³Agreed Statement of Facts at para. 116 and Exhibit 70 at T. 11B

⁴⁷⁴The list at Exhibit 70 T. 11B is a second production of the memo of August 20, 1990 (the first being AGC-4489)

has a different version of the list of sales. Whereas the list at AGC-4489 shows sales of 183; the list that is part of

Exhibit 70 shows sales of 199 (the number passed on to Lindsay Blaney by Francine Jacques which is the number

found in her hand writing on Exhibit 70 T. 3 and Exhibit 59 at T. 52 and for the English Translation also see:

Exhibit 59 T. 52)

⁴⁷⁵Transcript of Francine Jacques (June 18, 2019) at p. 34

⁴⁷⁶Ibid at pp. 33-34

⁴⁷⁷Agreed Statement of Facts para. 117

⁴⁷⁸Ibid at para. 118

Page: 144

Blaney indicate that the recall was completed on or by October 3, 1990.⁴⁷⁹On January 9, 1991,

Instrumentarium Inc. informed Health and Welfare Canada of the completed recall of Vitek TMJ

IPI implants. This included the number and type of Vitek TMJ Interpositional implant units

returned by purchasers. There were 37 of them.⁴⁸⁰

[425] Francine Jacques (Gaudette) was involved in the recall. During her testimony she was

referred to Information Letter 661 which is dated May 14, 1988, is addressed to “All Recipients

of Information Letters” and is entitled “Product Recall Procedures.⁴⁸¹She said:

This letter is very specific. It contains all the details. It was used as a basis for

our own general procedure. When we were looking at the recall procedure on the

firm side, we would refer them to information letter 661 to…For the details. How

they should proceed. It was like procedure… that.... ⁴⁸²

[426] Information Letter 661 was used to advise those at Health and Welfare Canada of their

responsibilities during a recall. It was not a regulation. It was guidance as to how they and

industry participants should carry out a recall:

The enclosed document entitled 'Product Recall Procedures' is currently being

used by the Health Protection Branch to facilitate our internal recall

responsibilities. I am, however, convinced that its contents can also be of benefit

to the relevant industries and I encourage its acceptance by you as a basic

guideline for the recall of food and drugs, cosmetics and devices. There is no

intention to promulgate these recall procedures into regulations.⁴⁸³

[427] It was made clear that the responsibility for developing a recall strategy lay with the

company involved, in this case, Intrumentarium Inc.:

It was the firm that was recalling the product. They had to develop their strategy,

and they had to inform by regulation, they had to inform the Health Protection

Branch that there was a recall ongoing if they were recalling a product, and then

we would monitor the recall, the efficiency of their recall, and we would evaluate

their recall strategy, was it — was it correct, pertaining to a particular situation.

We were there to see if it was acceptable and effective.⁴⁸⁴

[428] Francine Jacques (Gaudette) confirmed that the process was monitored by the Health

485

Protection Branch.

She was satisfied that the recall was effective, and that the method by

⁴⁷⁹Exhibit 71 at T’s 13, 14, 16 and 22

⁴⁸⁰Ibid at para. 119 and see Exhibit 70 T. 3 and Exhibit 59 T. 52 and for the English Translation also see: Exhibit

59 T. 52

⁴⁸¹Transcript of Francine Jacques (June 18, 2019) at p. 2 referring to Exhibit 60 T. 1

⁴⁸²Ibid at p. 9

⁴⁸³Ibid at p. 18 quoting Exhibit 60 T. 1

⁴⁸⁴Ibid at p. 19

⁴⁸⁵Ibid at p. 19

Page: 145

which Instrumentarium Inc. conducted the recall, which was to contact each surgeon directly,

was an appropriate way to proceed:

So, we were there …. I was there for the recall monitoring, 15 months later, 15-16

months later, they do the recall. I think the way the[y] used representatives to

contact the surgeons, the direct customers, was the best way to do [it]. It was an

adequate way to do [it] for this type of product.⁴⁸⁶

[429] In the circumstances, I do not think it of any value to disaggregate all of the actions taken

by or on behalf of the Crown to determine whether each and every one of the specifics of

Information Letter 661 (Product Recall Procedures) were followed. I repeat, it was a guideline.

In this case the recall was proficiently carried out, by the company, with the guidance of

representatives of Health and Welfare Canada. It was done in a short period of time and included

an inventory of the products imported, retained, sold, recovered and possibly implanted.

[430] The Plaintiff has cast a shadow over these events by submitting that there was product

imported directly and not through Instrumentarium Inc. and that it is the fault of Health and

Welfare Canada for not picking this up. I do not accept that there is sufficient substantive

evidence to confirm this is true. If it is true, the efforts made to notify those engaged in

implanting those devices of the problems associated with their use were appropriate and

reasonable. At the outset of her cross-examination and later Francine Jacques (Gaudette)

indicated that there was no evidence of anyone who had not been advised or received some form

of the several notifications that had been undertaken. There was a “slight possibility” that such a

person existed.⁴⁸⁷She had not encountered a single example of what she termed “private

importation”.⁴⁸⁸Francine Jacques (Gaudette) had looked at the customs manifests. This is what

caused her to review the database as to the status of the submissions made in respect of Vitek

Inc. products. Dr. Daniel Tomlak was the only Canadian physician to testify. He had implanted

Vitek Proplast implants. They were purchased from Instrumentarium Inc., which he understood

to be a reputable corporation in the field of medical devices. Elliot Wayne Tunis implanted 58

Proplast implants. They were purchased by the hospital. He used different types of Vitek

Proplast products in different cases; some were specially ordered; others were kept in stock.⁴⁸⁹

As in the case of Daniel Tomlak, the purchase of these implants was made through the head

nurse who was in charge of obtaining required materials. It was the nurse who approached those

at the hospital responsible for purchasing. At the time of the cross-examination, which was

accepted as evidence in this case, a document was put to Elliot Wayne Tunis. It was exhibited as

“Photocopy of Document Containing Entry Dated September 26, 1985 (The Ordering of a

Proplast Vitek 913.46 Fossa TMJ Prosthesis)”. The Exhibits were not produced with the

Transcript. There is no way of knowing if this document would have provided information as to

who sold the implant to the hospital. This is one place where the probative value of the cross-

examination of Elliot Wayne Tunis becomes an issue. There is nothing concrete that suggests the

implants he used were imported directly from Vitek Inc. To the contrary, the similarity with the

⁴⁸⁶Ibid at p. 47

⁴⁸⁷Ibid at p. 98

⁴⁸⁸Ibid at at pp. 99, 100 (“I did not encounter any instance where it had occurred.”)

⁴⁸⁹Transcript, Cross-Examination of Elliot Wayne Tunis on his affidavit sworn August 1, 2007 at pp. 61-63 and 67

Page: 146

circumstances of Daniel Tomlak suggests the purchase was from the only Canadian distributor,

Intrumentarium Inc.

[431] From April 1, 1991 to October 1, 1991 Francine Jacques (Gaudette) was seconded to be

the Supervisor of Drug Inspectors and, for that period was not responsible for the

Instumentarium Inc. file. For that time that responsibility was passed on to Denise Coté. ⁴⁹⁰On

December 9, 1991 Denise Coté sent a memo to Lindsay Blaney which included the following

sentence:

In addition, it should be kept in mind that “X” number of implants may have been

imported directly from the United States.⁴⁹¹

[Emphasis added]

[432] The use of the word “may” does nothing more than raise this as a possibility in the

absence of any supporting material.

[433] On October 16, 1992 Francine Jacques (Gaudette) had returned to her responsibilities as

an inspector in respect of medical devices. On that day she prepared a memorandum which

reviewed the actions that had been taken by the Health Protection Branch as “summarized” in the

memo of December 9, 1991 written by Denise Coté. The memorandum prepared by Francine

Jacques (Gaudette) included a recommendation:

It would appear necessary for the department to send a letter to all physicians and

dentists in Canada to ensure that all those affected are aware of the importance of

patients with Vitek and OSMI TMJ IPIs VK, VK-I and VK-II implants being

examined. The Department could use this opportunity to include a note about

Vitek’s other implants whose notices of compliance were revoked as a result of

the bankruptcy. A sample letter could be sent with the latest FDA notice is

attached. ⁴⁹²

[434] The rationale for this recommendation is one of a series of recitals (whereas clauses) that

lead to it:

Whereas it seems certain that it was possible to purchase this product directly

from the United States and it was in that case not covered by this recall conducted

by Instrumentarium.

[Emphasis added]

⁴⁹⁰Transcript of Francine Jacques (June 18, 2019) at p. 62

⁴⁹¹Exhibit 60 T. 5

⁴⁹²Exhibit 65 (English) and see Exhibit 59 T. 64 (French) The English translation is dated “September 92”.

Apparently, the correct date, as appears on the French original is October 16, 1992.

Page: 147

[435] This is from an English translation of a memorandum originally written in French. Even

accounting for the vagaries of relying, in too refined a way, on a translation, the idea that it

“seems certain” that some act was “possible” is a considerable distance from a concrete

demonstration that the thing, whatever it might be, actually happened.

[436] The Submissions of the Plaintiff note this “letter” as saying “…that there was an

unknown quantity of implants that had been purchased from the U.S.”⁴⁹³The memorandum

(“letter”) does not say that. It says what is quoted above. In her evidence Francine Jacques

(Gaudette) said that there was a concern for the possibility of private, direct importation to

doctors on the list of 200 Canadian doctors. She went on to say that none was ever identified:

Yeah. After I became aware that they had seized [a list] of 200 doctors, Canadian

doctors…I thought we, we had the thought that maybe there would have been one

of them that would have got the product, but I never encountered any proof of

that.

THE COURT: Okay

It does not mean that it did not occur, but I have never seen any indication that it

was the case.

THE COURT: All right Mr. Steeves.

MR. STEEVES: Q. And is it possible that more than one doctor could have

engaged in a private importation?

That’s all speculation and maybe there was none because what was this, this used

for, I don’t know and the FDA did not know.⁴⁹⁴

[437] This does not, as the Submissions of the Plaintiff imply, raise the spectre of untold

numbers of privately imported implants. The Submissions of the Plaintiff declare that it should

have been clear to Francine Jacques (Gaudette) that there had been private importing of Vitek

Proplast implants. The Submissions refer to a report prepared by Francine Jacques (Gaudette)

following her visit to Instrumentarium, Inc. on August 21, 1990 made in conjunction with the

recall. The report is dated August 23, 1990. The report includes handwritten notes of Lindsay

Blaney which, among other things, identify that 199 such implants had been sold by

Instrumentarium Inc. This number is broken down to show 68 sold in British Columbia, 34 sold

in Alberta, 95 sold in Ontario and 2 sold in Nova Scotia. The Submissions of the Plaintiff turn to

a memo attributed to Robert Scales A/Medical Device Specialist, Health Protection Branch,

Winnipeg, Manitoba.⁴⁹⁵The memo refers to a Manitoba physician (no name is noted) that

implanted two Proplast implants. From this the Submission concludes:

⁴⁹³Submissions of the Plaintiff at para. 423

⁴⁹⁴Transcript of Francine Jacques (June 20, 2019) at p. 9

⁴⁹⁵Exhibit 59 T. 42

Page: 148

Given Instumentarium’s customer records noted above [the breakdown referred

to], this Manitoba surgeon secured these implants through private importation.⁴⁹⁶

[438] The memorandum of Robert Scales is clear. The two implants used by the Manitoba

surgeon were not privately imported. Like the doctors in Thunder Bay they were purchased from

Instrumentarium, Inc.:

Three of the doctors had not implanted any of the devices and the other had

implanted two of them. He indicated that no problems had occurred with the

device. He had obtained the implants from Instrumentarium.⁴⁹⁷

[439] Obviously, there is an error. Either the records of Instrumentarium Inc. were incomplete,

the Manitoba implants were recorded but missed in the review, they were located through

purchase in another province or the Memorandum of Robert Scales is inaccurate. There is no

way of knowing where the error lies but there is no reason to jump, as the Submissions of the

Plaintiff do, to the conclusion that these two implants were privately imported. What is clear is

that if any implants were privately imported, there were very few.

[440] On October 13, 1992, Francine Jacques (Gaudette) sent the following letter (memo) to

the “Chief, Drug and Environmental Health Division” in each of five regions explaining that the

recommendation that a letter be sent to all physicians and dentists in Canada had been passed on

to the Field Operations Directorate. The justification was different. The recommended letter to

“all physicians and surgeons” was not due to a concern for “private importation” but in

furtherance of the following up of letters sent by the United States Food and Drug

Administration to surgeons that had been returned because the addresses were incomplete:

You will find attached envelopes containing the FDA Safety Alert relating to the

above-mentioned recall that were originally sent by FDA to oral and maxillofacial

surgeons located in your region and returned to FDA for incorrect addressing.

You will note that the postal code is incomplete.

Would you please try to locate the surgeons and forward them this important

information. A suggestion of covering letter is attached.

Please take note that FDA took this list of surgeons in Vitek’s file and it dates

somewhat [sic]. For example, in Québec Region we discovered that some

surgeons have moved and others retired. Vitek filed for bankruptcy in 1990 after

the recall had been initiated. For your information a recommendation has been

made to FOD that we advise every dentist and doctor in Canada about this Safety

Alert.

Please do not hesitate to contact the undersigned should you need any more

information.

⁴⁹⁶Submissions of the Plaintiff at para. 440

⁴⁹⁷Exhibit 59 T. 42 and Transcript of Francine Jacques (June 21, 2019) at p. 51

Page: 149

Francine Jacques Gaudette⁴⁹⁸

[Emphasis added]

[441] This recommendation was not followed. It is not necessary that every recommendation

made be followed in order to demonstrate that a duty of care, if one is found to exist, has not

been breached. In this case, a relatively small number of doctors were involved, a relatively

small number of the offending devices had been shown to have been implanted and only the

possibility of private sales had been raised. It was reasonable to determine that communicating

with “every dentist and doctor in Canada” was not appropriate. It is not difficult to surmise that

the upset and alarm that such a broadly cast communication could cause would more than offset

the chance of missing some unidentified and illegal direct sale. As it is, there is evidence that the

primary request, in the correspondence from Francine Jacques (Gaudette), that letters to doctors

returned due to incorrect addresses be resent was met. This being so, her correspondence

achieved its stated purpose. On November 3, 1992, Sharon Noel, Food and Drug Inspector,

Halifax wrote to Francine Jacques (Gaudette):

As requested in your memo dated 13 October 1992, the following oral surgeons

were resent the letters from FDA on 2 November 1992. I have also enclosed their

new mailing addresses for your information.

[442] The Submissions of the Plaintiff expresses a concern for the foundation of the decision

not to send letters to each and every physician and surgeon in Canada. The suggestion was made

that Francine Jacques (Gaudette) passed this recommendation on to “doctors and scientists

within Health Canada’s scientific group to make on the basis of science or health information”⁴⁹⁹

and that this decision was not made on that basis. First, Francine Jacques (Gaudette) did not pass

this on to those who made the decision because they were doctors or scientist but because they

were the ones who were responsible for making this decision. Secondly, as described above,

those who made the decision had to go beyond science and health and consider the overall

context in which all this took place. Thirdly, as will become clear, there were other efforts made

to notify physicians and surgeons of the concerns with Vitek Proplast implants. And finally, it is

not clear that the decision to which the Submissions of the Plaintiff refers concerned letters to be

sent to physicians and surgeons. Rather it had to do with the publication of a news release related

to a settlement of corresponding litigation in the United States:

MR. STEEVES: Q. Madam Jacques, you said that when it came to decisions on

whether the press release was to go further, you placed that in the hands of others.

You did not have jurisdiction. It was not your role to determine national

communication. Is that correct?

A. It is correct. And if you look at letter that we discussed this morning, 661, the

authority to go to a press release it is the assistant deputy minister that has the

authority to do that.

⁴⁹⁸Exhibit 61A T. 41

⁴⁹⁹Submissions of the Plaintiff at para. 442

Page: 150

…

Q. So, I guess my question is, it appears that the determination not to go forward

with this appears to be based on the fact that there was an inaccuracy with Vitek

settlement data, not necessarily science. Is that what that email reads? And you

received it.

A. Yeah, I received it. That was not my decision and it was not a decision for me

to take. As I said, I brought the point, I thought, to explain my recommendation

and then it was not for me to decide. It was scientific decision to be taken by the

scientists. Not for me. I think the inaccurate thing they are referring to is a

settlement in the States. But I cannot speak to that further because I was not

involved in that at all.⁵⁰⁰

[443] Lindsay Blaney explained why this sort of broad general notification was not thought to

be necessary in Canada while being undertaken in the United States:

What we need to understand is that by the time Francine is sending me this memo,

December 1991, the recall in Canada has been conducted. It was an effective

recall. By that date, December 1991, we had three targeted public warnings in the

relevant Canadian Health Practitioner Association Journals and Newsletter. I’ll

say it again. There was one in the Canadian Dental Association Journal in April

1991. There was another one in the Canadian Dental Association Journal in

August 1991; and there was another one through Dr. Freeland’s letter in the

November edition of the Canadian Association of Oral and Maxillofacial

Surgeons.

So, by that date in Canada, there was a recall that had been conducted. All

surgeons, hospitals, had been made aware of this issue. They had been informed

to conduct proper clinical follow-up care on their patients. We had a community

of dental practitioners who were aware of this issue, and Vitek products were no

longer sold in Canada.

So, that’s the situation in Canada, and we’re dealing with 162 possibly implanted

implants.⁵⁰¹

[444] These were not the only activities that responded to the difficulties associated with Vitek

TMJ implants.

[445] On January 7, 1991, the United States Food and Drug Administration issued a news

release announcing its recall of Vitek TMJ implants and urging dental surgeons “to x-ray patients

with these implants to determine whether they are experiencing complications” and if there were

⁵⁰⁰Transcript of Francine Jacques (June 18, 2019) at p. 131-132

⁵⁰¹Transcript of Lindsay Blaney (September 20, 2019) at p. 34

Page: 151

no complications, to have patients re-examined every six-months.⁵⁰²The next day (January 8,

1991), the United States Food and Drug Administration advised state health officers, boards of

pharmacy, state drug officials and state device officials about the recall of Vitek TMJ implants.

The United States Food and Drug Administration again advised dental surgeons to re-examine

patients with these implants and return any unused stock.⁵⁰³On February 1, 1991, the United

States Food and Drug Administration announced the reclassification of Vitek TMJ Implants as a

Class I recall based on a study of the composition of the implant material and evaluations of

patients who reported complications from the implants.⁵⁰⁴A Class I recall involves situations “in

which there is a reasonable probability that the use or exposure to, a violative product will cause

serious adverse health consequences or death.”⁵⁰⁵

[446] By letter dated March 29, 1991, sent separately, to both Dr. E. LeTourneau,

Environmental Health Directorate and Dr. D. L. Johnson, Bureau of Medical Devices, the United

States Food and Drug Administration advised the Health Protection Branch of the Class I recall.

The letter is a demonstration of the recognition and need for international cooperation in the

circumstances such as this. I quote it in full:

Dear Dr. [LeTourneau/Johnson]

At the 1986 International Conference for Medical Device Regulatory Authorities

(ICMDRA) there was a broad consensus regarding the need for communication

and cooperation among government officials with national responsibility for

medical devices.

In the spirit of ICMDRA, I would like to inform you of a Class I recall conducted

by the Vitek, Inc. Under the U. S. System the recall is conducted by the firm, but

is monitored by the Food and Drug Administration (FDA). In the case of a Class I

recall, i.e. One where there is significant risk to patient health, the firm is

required to account to FDA for every item effected [sic] by the recall.

The Vitek Inc., recall was initiated because FDA had determined that the failure

of these devices could expose patients to a high degree of serious adverse health

consequences including bone degradation and foreign body response by the

immune system. Enclosed are copies of an FDA Safety Alert and a press release

which fully describes problem and corrective action necessary.

Some of the goods affected by this recall were shipped to consignees in your

country. If you have any questions, please contact [the bankruptcy trustee for

Vitek and a FDA official are named].

⁵⁰²Agreed Statement of Facts at para. 63

⁵⁰³Agreed Statement of Facts at para. 64

⁵⁰⁴Ibid at para. 65

⁵⁰⁵Ibid at para. 65

Page: 152

The Center for Devices and Radiological Health (CDRH), FDA, has been

designated the WHO Collaborating Centre for Training and Consultation in the

Public Health Aspects of Medical Devices. We look forward to international

cooperation in the efforts to promote the safe and effective use of medical

devices.

Sincerely yours,⁵⁰⁶

[Emphasis added]

[447] Typically, the elevation of a recall from Class II to a Class I recall would be a matter of

significance. The classification of recalls is reviewed in Information Letter 661 (“Product Recall

Procedures”):

“Recall classification” means the numerical designation, i.e. Class I, Class II, or

Class III, assigned by the Health Protection Branch to a particular product recall

to indicate the relative degree of health hazard presented by the product being

recalled.

(1) Class I is a situation in which there is a reasonable probability

that the use of, or exposure to, a violative product will cause

serious adverse health consequences or death.

(2) Class II is a situation in which the use of, or exposure to, a

violative product may cause temporary adverse health

consequences or where the probability of serious adverse health

consequences is remote.

(3) Class III is a situation in which the use of, or exposure to, a

violative product is not likely to cause any adverse health

consequences.

[448] The change from Class II to Class I reflects the recognition that something which had

been thought to represent a probable risk of only temporary consequences, in fact, poses a threat

of serious adverse consequences. The letter to Drs. LeTourneau and Johnson described that, with

the change, there was a requirement to account for “every item effected [sic] by the recall”. By

this time, in Canada, this was already known.

[449] During April 1991, Francine Jacques (Gaudette) was contacted by Denise Coté. This was

at the time Francine Jacques (Gaudette) was acting as supervisor of the Drug Inspection Unit and

responsibility for the Instrumentarium Inc. file had been passed on to Denise Coté. Benoit

Toupin, Supervisor, Medical Devices Unit for the Québec Region, had been told, by a memo

⁵⁰⁶Exhibit 70 T. 5 and Exhibit 60 T. 3 as well as Agreed Statement of Facts at paragraph 66. It is referenced at

Transcript of Francine Jacques (June 18, 2019) at pp. 65-66

Page: 153

dated April 23, 1991, that in the United States the recall had been converted to a Class I recall.⁵⁰⁷

This was considered by Francine Jacques (Gaudette) to be an important document. The fact of

the reclassification from a Class II to Class I recall was important information.⁵⁰⁸I will turn to

the response of Health and Welfare Canada shortly.

[450] There were further efforts to notify those involved in the implanting of Vitek Proplast

devices.

[451] On January 28, 1991, Health and Welfare Canada asked the Canadian Dental Association

(“CDA”) to publish in its Journal a communication from the Health Protection Branch and

Vitek’s Voluntary Safety Alert of March 23, 1990.⁵⁰⁹The letter makes clear the purpose behind

the request. It said, in part:

I would like to thank you Dr. Crawford, and “the Canadian Dental Association”

for your cooperation in this matter as your journal is an excellent vehicle to

expose your members to this information, which otherwise they may have

overlooked.⁵¹⁰

[452] The Voluntary Safety Alert of March 23, 1990 was reprinted in the Canadian Dental

Association Journal in April 1991 (Vol. 57 No. 4).⁵¹¹It was introduced through a Health

Protection Branch Communication, the first sentence of which restated the purpose of publishing

the Voluntary Safety Alert:

The Health Protection Branch (HPB) wishes to ensure that every dental surgeon

concerned is made aware of the following Voluntary Safety Alert issued by Vitek

Inc. in 1990.⁵¹²

[453] Prior to the request for the reprinting of the Voluntary Safety Alert in the Canadian

Dental Association Journal, the United States Food and Drug Administration issued its own

notice. This one was a FDA Safety Alert subtitled: “Serious Problems with Proplast Coated TMJ

Implant”.⁵¹³It is dated December 28, 1990 and is addressed to “Oral and Maxillofacial

Surgeons” and advised that:

This is to urge you to re-examine all of your patients who have received

temporomandibular joint (TMJ) interpositional implants which were

manufactured or marketed by either Vitek Inc. or Oral Surgery Marketing Inc.

(both of Houston Texas). These implants were distributed between February 1983

and June 1988 and were the subject of Vitek’s March 23, 1990 safety alert.

⁵⁰⁷Transcript of Francine Jacques (June 18, 2019) at pp. 63-64 and Exhibit 60 T.3

⁵⁰⁸Ibid at p.64

⁵⁰⁹Agreed Statement of Facts at para. 120

⁵¹⁰Ibid see footnoted document

⁵¹¹Exhibit 70 at T. 10

⁵¹²Ibid

⁵¹³Exhibit 70 T. 4 also at Exhibit 49 T. 14

Page: 154

[454] It stated the problem as:

These implants, all of which are made of Proplast^R(Teflon^R, carbon or Teflon^R-

aluminum oxide fiber composite), have been associated with implant perforation,

fragmentation and/or a foreign body response that may result in progressive bone

degeneration of the mandibular condyle and/or glenoid fossa (1-3). If bone

degeneration continues unchecked, patients may experience intense pain and

severely limited joint function. One study found that all patients with Proplast^R-

coated TMJ interpositional implants who experienced complications

demonstrated progressive bone degeneration in as little as 1 to 2 years (1). In a

second study, implant failure and bone degeneration occurred in both

symptomatic and asymptomatic patients (2).

[455] The footnotes internal to this paragraph (the numbers (1) and (2)) refer to two academic

papers which are said to support the points, in the quotation, with which they are associated. The

first is dated May 1987 and the second May 1989.⁵¹⁴These are both Masters’ Thesis and do not

appear to have been published.

[456] The FDA Safety Alert goes on to include recommendations as to how the patients with

these Vitek TMJ Interpositional Implants should be examined and, depending on the results,

followed up and treated.

[457] I return to the response of Health and Welfare Canada to the reclassification, by the

United States Food and Drug Administration, of the recall from a Class II to Class I recall. The

reclassification in the United States to a Class I recall was a catalyst for the further notifications

that continued after the recall by Instrumentarium Inc. had been completed.⁵¹⁵This is contrary to

the position adopted in the Submissions of the Plaintiff which states:

In the U.S., however, the FDA expanded their public health advisory to include

all Proplast TMJ or IPI implants, including the VK and VKI implants. In Canada,

there was no expansion of the recall. At the time of her 1990 visit, Ms. Jacques

detained those items that didn’t have a notice of compliance. See Exhibit 49 tab

30. This meant that the Proplast block and sheeting which could be used for TMJ

⁵¹⁴Footnote (1) refers to: Primley, Donald, Jr. "Histological and Radiographic Evaluation of the Proplast-Teflon

Interpositional Implanted in Temporomandibular Joint Reconstruction Following Meniscectomy, Thesis, Masters

Degree in Oral Maxillofacial Surgery, May 1987. University of Iowa

Footnote (2) refers to: Westlund, Kurt., "An Evaluation Using Computerized Tomography of Clinically

Asymptomatic Patients Following Meniscectomy and Temporomandibular Joint Reconstruction Using the Proplast-

Teflon Interpositional Implants", Thesis, Masters Degree in Oral and Maxillofacial Surgery, May 1989. University

of Iowa

⁵¹⁵Transcript of Francine Jacques (June 18, 2019) at pp. 64-74

Page: 155

interpositional implants, and the VK type Proplast TMJ devices, all of which had

NOCs, were never detained, and continued to be distributed for use in Canada.⁵¹⁶

[458] To my mind this paragraph is, in part, misleading and, in part, wrong. There was no

reclassification of the recall because at that point there was not one. The recall had been

completed earlier on October 3, 1990 (see para. [424] above). Nonetheless, as will be described,

there was considerable continued effort to notify those involved. Moreover, as I have already

reviewed, “the TMJ interpositional implants, and the VK type Proplast TMJ devices” did not

receive Notices of Compliance. So far as I am concerned the suggestion that these devices had

received such notices is a fundamental flaw in the position taken of behalf of the Plaintiff which

is repeatedly relied on in the submissions made on her behalf. As for Block and Sheeting, the

intention was that their use be limited to facial and not orthopaedic issues. To the extent that the

applicable product monograph could be misread (there is no example of this having happened)

the uses the monograph describes are broad and general leaving it to the oral surgeon to decide

whether or not the contraindications apply to a particular patient.

[459] With the FDA Safety Alert in hand, Denise Coté discussed the situation with Francine

Jacques (Gaudette). She followed up with Lindsay Blaney; they spoke on the telephone. Denise

Coté confirmed the conversation in a handwritten Memorandum:

News release-Safety alert regarding Vitek TMP IPIs

I am writing to follow up on our telephone conversation of May 16, 1991,

regarding the suggestion to publish a copy of the FDA safety alert (December 28,

1990) in the journal of the Canadian Dental Association.

Once you have made a decision, I will notify Instrumentarium of our plan, where

necessary.

Pease find attached a proposed text for publication in the journal.⁵¹⁷

[460] On June 4, 1991 the Health Protection Branch requested that the Canadian Dental

Association publish, in its Journal, a second message concerning Vitek’s TMJ IPI devices along

with the FDA’s December 28, 1990 Safety Alert. The message referred to is included in the

request as:

The Health Protection Branch wishes to ensure that every dental surgeon

concerned is made aware of the second Safety Alert (see below) issued by the

Food and Drug Administration of the United States on December 28, 1990. The

first Alert had been published by Vitek Inc. on March 23, 1990. ⁵¹⁸

⁵¹⁶Submissions of the Plaintiff at para. 417

⁵¹⁷Exhibit 60 at T. 4

⁵¹⁸Agreed Statement of Facts at para. 123 and Exhibit 70 at T.6. The message is, as proposed by Denise Coté,

included with her Memorandum of May 16, 1991 (Exhibit 60 at T. 4 )

Page: 156

[461] The FDA Safety Alert was reprinted in the Canadian Dental Association Journal in

August 1991 (Vol. 57 No. 8) in both French and English.⁵¹⁹

[462] On June 18, 1991, the BRMD [Bureau of Radiation and Medical Devices] received, from

the United States Food and Drug Administration, a copy of the list of Canadian “consignees”

(doctors and surgeons) who, it was said, had purchased the Vitek TMJ IPI devices.⁵²⁰This was

further to advice that had been provided three weeks earlier, on May 28, 1991 at a Tripartite

Meeting involving representatives of the United States Food and Drug Administration, the

United Kingdom’s Department of Health and Social Security and Health and Welfare Canada,

when Canadian officials were advised by their American counterparts of a list of “Canadian

consignees who had purchased devices, including but not limited to Vitek TMJ implants”.⁵²¹

This was also further to the letters dated March 29, 1991 from the United States Food and Drug

Administration to both Dr. E. LeTourneau, Environmental Health Directorate and Dr. D. L.

Johnson, Bureau of Medical Devices which noted that product of concern had been shipped to

Canadian consignees (see: para. [446] above). In a handwritten memo to file (“Dossier”) Denise

Coté advised that the list had been transmitted to the Association of Oral and Maxillofacial

Surgeons.⁵²²

[463] On or around June 25, 1991, Instrumentarium Inc. advised Health and Welfare Canada

that it was no longer selling certain Proplast products in Canada.⁵²³

[464] On September 6, 1991, a letter signed by W. Freeland M. D. as the Acting Chief, Clinical

Advisory Division of the Health Protection Branch of Health and Welfare Canada was delivered

to Dr. Aron Gonshor President, Canadian Association of Oral and Maxillofacial Surgeons. The

letter refers to the voluntary recall of interpositional implants manufactured and marketed by

Vitek Inc. in the United States (the Voluntary Safety Alert of March 23, 1990); to the fact that

these implants were never given a Notice of Compliance by Health and Welfare Canada for sale

of those devices in Canada and to the information recently received from the United States Food

and Drug Administration identifying “that about 200 Canadian Dentists/Oral Surgeons received

these devices for implantation in their patients in Canada”.⁵²⁴In her viva voce evidence, more

than once, Lindsay Blaney, expressed doubt that each of the 200 “consignees” had, in fact,

purchased interpositional implants manufactured by Vitek Inc. She noted that only 199 of these

implants had been sold by Instrumentarium (the sole Canadian distributor) and “possibly” 162 of

these devices had been implanted.⁵²⁵This being so it seems unlikely that all 200 of the

consignees had purchased interpositional implants manufactured by Vitek Inc. Lindsay Blaney

indicated that the people at Health and Welfare Canada (“we”) were unsure as to what was meant

by the word “consignees”:

⁵¹⁹Exhibit 70 at T. 10

⁵²⁰Agreed statement of Facts at para. 124 and Exhibit 70 T. 7

⁵²¹Ibid at para. 67

⁵²²Exhibit 70 at T. 8

⁵²³Agreed Statement of Facts at para. 125

⁵²⁴Ibid at para. 126 and Exhibit 70 at T. 9

⁵²⁵Exhibit 70 T. at 3 and Exhibit 59 T. 52 and for the English translation also see: Exhibit 59 at T. 52)

Page: 157

We don’t really know what they meant by that word because we eventually came

to the realization that not all names on that list had purchase[d] implanted the

devices.⁵²⁶

[465] She posited that the 200 listed consignees were Canadian oral surgeons who had

expressed an interest in the product and not those who had purchased any:

So it appears like this is what it might have been, a list of oral surgeons that were

on their mailing list and interested in receiving any information on their

products.⁵²⁷

[466] Be that as it may, the fact is that the letter of September 6, 1991 was sent to Dr. Aron

Gonshor with the request that it be published in the Newsletter of the Canadian Association of

Oral and Maxillofacial Surgeons.⁵²⁸As it transpired the letter of September 6, 1991 was

misplaced during a postal strike. Another copy was faxed to Dr. Aron Gonshor on October 10,

1991 “for publication”.⁵²⁹Lindsay Blaney testified, and the documents indicate, that the letter

was published in the November, 1991 issue of the Canadian Association of Oral and

Maxillofacial Surgeons Newsletter. It followed what was referred to as an “IMPORTANT

NOTICE”:

The legacy of the Vitek temporomandibular joint prosthesis continues, although

the company and the product are no longer around. A recent letter from the

Bureau of Radiation and Medical Devices, Health and Welfare Canada, is

reproduced below for your information and action if appropriate. If there are any

questions regarding management of any of your patients in regard to the

prosthesis, inquiries can be directed to:

[The name, address and phone number of a Consultant Physiologist with the

Clinical Advisory Division, Bureau of Radiation and Medical Devices were

provided.] ⁵³⁰

[467] In furtherance of the idea that the list did not demonstrate doctors who purchased, but

those who may have expressed an interest, I note that a year later, on September 16 and 18, 1992

Francine Jacques (Gaudette) tried to contact all the oral and maxillofacial surgeons in Quebec

whose names were on the list of “about 200” received from Vitek Inc. By my count there were

29 doctors from Quebec on the list. She managed to reach 7, not one of whom had implanted

⁵²⁶Transcript of Lindsay Blaney (September 17, 2019) at p. 74

⁵²⁷Ibid at p. 74 (Health Canada was advised of the existence of the list at the tripartite meeting of the United States

Food and Drug Administration, the United Kingdom Department of Health and Social Security and Health Canada

(Agreed Statement of Facts at para. 67). It was in June 1991 that Health Canada received the list (Transcript of

Lindsay Blaney (September 19, 2019) at pp. 52-53))

⁵²⁸Exhibit 70 at T. 9

⁵²⁹Exhibit 70 at T. 12

⁵³⁰Exhibit 70 at T. 10

Page: 158

“the device.”⁵³¹Interestingly, they were all aware that problems with Proplast implants had

appeared, some through the notices from the United States Food and Drug Administration and

others through the publication of these concerns in various journals. I repeat that on October 13,

1992 Francine Jacques (Gaudette) sent a letter to the five regions requesting that where the

letters to these “consignees” had been returned, follow up letters be sent. This direction was

followed (see para. [441] above). This tends to confirm the likelihood that all of the health

professionals involved with these products had already been alerted to the difficulties that had

become apparent.

[468] As testified to by Lindsay Blaney, the recall was complete. Even so, there was a further

notification to ensure that oral surgeons undertook to, and did follow up, with their patients who

had received Vitek Inc. temporomandibular implants. Concerns did not end with the completion

of the recall. In the United States the recall had been applied only to interpositional implants

referred to in the Safety Alert of December 28, 1990. The interest now extended to a broader

range of Vitek implant products.

[469] In September 1991, the United States Food and Drug Administration issued Public

Health Advisories on Vitek Proplast TMJ implants to health professionals, patients and Vitek

consignees. These advisories were not limited to interpositional implants but also related to VK

(glenoid fossa), VK-1 (condylar head, glenoid fossa) and VK-II implants. The advisories sought

to identify all patients with the implanted devices and have them re-examined and monitored.

The advisories indicated that the United States Food and Drug Administration considered the

implanted devices to “present a hazard to the health of patients” and advised that a special

registration program for all Vitek TMJ patients had been established.⁵³²

⁵³¹Exhibit 63 (Memo: “Conversations With Oral Surgeons”) in particular see p. 2: “No one said they had implanted

the device.”

⁵³²Agreed Statement of Facts at para. 68 referencing AGC-04890 (Dear Health Professional and Vitek Consignee)

also see Exhibit 49 at T. 30 (Dear Health Professional)

While the catalogue numbers associated with the material filed in support of the request for Notices of Compliance

demonstrate that, in Canada, there was a distinction between Vitek Interpositional Implants as opposed to TMJ

Fossa Prosthesis, Type VK and TMJ Condylar Prosthesis, Type VK (see: Exhibit 12 at T. 32 at pp. 000012 and

000013) it is not so clear that the difference was part of the treatment extended to these products by the United

States Food and Drug Administration. I say this because AGC-04890 relied on in the Agreed Statement of Facts

begins:

Dear Health Professional and Vitek Consignee:

The United States Food and Drug Administration (FDA) request that you notify all patients of the

problems associated with the following temporomandibular joint (TMJ) interpositional implants

manufactured by Vitek, Inc., Houston Texas:



TMJ interpositional implant (IPI)

VK (glenoid fossa)

VK-I (condylar head, glenoid fossa)

The concerns about the IPI or expressed in FDA's December 28, 1990 Safety Alert (copy

enclosed).

…

Page: 159

[470] During October 1991, the American Academy of Oral and Maxillofacial Surgeons

published in its “Digest” the United States Food and Drug Administration’s September 1991

Public Health Advisory on Vitek Proplast TMJ implants.⁵³³

[471] In the same month (October 1991), the United States Food and Drug Administration:



published an article in the “Medical Devices Bulletin” about risks associated with

TMJ implants. The article stated that on October 2, 1991, the United States Food

and Drug Administration advised patients with Vitek TMJ IPI devices to be

examined and monitored by their surgeons or dentists and further advised about

the establishment of the registration program for all Vitek TMJ patients;⁵³⁴

on October 2, 1991, issued a “Medical Alert” and a press release concerning the

risks associated with Vitek TMJ IPI devices and of the registration program that

had been established. The press release recommended that patients obtain an

immediate examination to determine whether the implants were breaking down or

causing bone degeneration;⁵³⁵and

on October 28, 1991, informed foreign regulatory agencies of Vitek TMJ IPI

device sales within their countries and remedial measures that it had taken

To my mind, this is at best ambiguous as to whether Interpositional Implants stand apart or are an all-inclusive term.

It would seem that Doran Ryan in the Expert Report he filed (Agreed Statement of Facts at Tab 20 p. 28) does not

share this concern:

Also, in September 1991 the US FDA issued a Public Health Advisory superceding the 1990

Safety Alert and containing specific recommendations for the follow-up of patients who had

received Proplast-Teflon IPIs as well as Vitek genoid fossa and condylar implants.

This uncertainty does not exist in the second of the two documents referred to in the Agreed Statement of Facts at

para. 68 being AGC-04892 which begins:

Dear TMJ Patient:

This letter contains important health information for persons who have or have had jaw implants

manufactured by Vitek these include the temporomandibular joint (TMJ) interpositional

implants (IPI), VK and VK-I. The information contained in this letter also applies to individuals

with a VK-II TMJ implant manufactured by Oral Surgery Marketing Inc., a successor

corporation of Vitek.

⁵³³Agreed Statement of Facts at T. 20 (Dr. Doran Ryan Expert Report) p. 29

⁵³⁴Ibid at para. 70

⁵³⁵Ibid at para. 71. Again, the Agreed Statement of Facts refers only to "Vitek TMJ IPI devices" where the first of

the two documents speaks of "certain jaw implants manufactured by Vitek Inc. of Houston…" The second document

mentions a broader array of Vitek TMJ implants:

The implants in question include Vitek interpositional (IPI), Vitek-Kent (VK), and Vitek-Kent I

(VK-I) TMJ implants….[and]…VK-II TMJ implant…

Page: 160

namely: the establishment of a notification program to identify and notify both the

surgeons who had implanted the devices and the patients who received them;

advising patients to seek regular appropriate medical examination; and the

initiation of an international patient registry, which would allow the United States

Food and Drug Administration to contact patients and surgeons to relay new

information to them as soon it became available.⁵³⁶

[472] On December 1, 1991, the United States Food and Drug Administration issued a

“Medical Bulletin” notifying physicians and patients about risks associated with Vitek implants

and the need for diagnostic examinations of patients. It also provided information on how to

enroll in the international patient registry.⁵³⁷

[473] On May 29, 1992, the United States Food and Drug Administration issued an “Important

Alert” for “implantable devices consisting in whole or in part of Proplast, Proplast II, or Proplast

HA.⁵³⁸In August 1992, the American Academy of Oral and Maxillofacial Surgeons circulated a

TMJ Implant Advisory.⁵³⁹In November 1992, the American Academy of Oral and Maxillofacial

Surgeons convened a workshop in Chicago to review the knowledge, use and management of

alloplastic TMJ implants.⁵⁴⁰In July 1993, the American Academy of Oral and Maxillofacial

Surgeons redistributed its TMJ implant advisory, originally published in August 1992, to United

States and Canadian fellows, members, life and retired members, candidates, residents and

affiliate members. The advisory included the United States Food and Drug Administration’s

current recommendations on Vitek’s Proplast TMJ implants.⁵⁴¹In October 1993, the American

Academy of Oral and Maxillofacial Surgeons published “Recommendations for the Management

⁵³⁶Agreed Statement of Facts at para. 72

⁵³⁷Ibid at para. 73. The first of these two documents is the Medical Bulletin. It refers to the broader array of Vitek

Implants:

The Implants in Question Include the Vitek Interpositional (IPI), Vitek-Kent (VK), and Vitek-

Kent I (VK-I) TMJ implants. Oral Surgery Marketing, Inc. (OSMI), of Houston, a successor

corporation of Vitek also manufactures a VK-II implant that may present similar risks.

A search of the second document (Retrieval Analysis Study) does not reveal any reference to either the date

(December 1, 1991) or to any "Medical Bulletin".

⁵³⁸Ibid at para. 74

⁵³⁹Ibid at para. 75

This document appears to deal with all Vitek Proplast TMJ implants. It begins:

Prompted by problems resulting from the Vitek Proplast Teflon TMJ implants, the House of

Representatives government operations human resources and intergovernmental relations

subcommittee held a hearing on June 4, 1992, in Washington, DC. The focus of the hearing was

whether the Food and Drug Administration (FDA) and National Institute of Health (NIH) have

failed to act appropriately to protect the public from the inadequacies of TMJ implants.

⁵⁴⁰Ibid at para. 76 and T. 24 (Retrieval Analysis Study)

⁵⁴¹Ibid at para. 77

Page: 161

of Patients with Temporomandibular Joint Implants” in the Journal of Oral and Maxillofacial

Surgery, based on the workshop that had occurred in November 1992.⁵⁴²

[474] What is plain from the preceding paragraphs is that in the period following the closing of

the Canadian recall (be it on October 3, 1990 as reported in the chronologies or January 9, 1991

when Instrumentarium notified Health and Welfare Canada) the continued use and impact of a

larger grouping of Proplast TMJ implants remained of interest and concern, particularly in the

United States.

[475] By 1994, as testified to by Lindsay Blaney, more information was available with respect

to temporomandibular joint implants. The concern in the United States extended beyond Vitek

Inc. to all alloplastic TMJ implants. This was manifested in a letter dated July 15, 1994 from the

Director, Center for Devices and Radiological Health to: “Orthopedic Surgeons,

Otolaryngologists, Plastic and Reconstructive Surgeons”. It begins:

The Food and Drug Administration (FDA) is aware that you may see patients who

have received temporomandibular joint (TMJ) implants. We are writing to inform

you about the potential problem with these implants.

Enclosed is a copy of the 1990 FDA Safety Alert sent to all U. S. oral and

maxillofacial surgeons urging them to re-examine their patients with Proplast^R-

coated TMJ implants. This Alert describes the signs and symptoms of problems

associated with Proplast^R-coated TMJ implants and provides recommendations

for management of patients. We request that you follow the recommendations in

the Alert in evaluating your clients with these types of implants. In addition, the

American Academy of Oral and Maxillofacial Surgeons (AAOMS) published

recommendations for management of patients with TMJ implants in its

professional journal in October 1993. These recommendations address the

management of patients with the following three types of alloplastic TMJ

implants: Teflon-Proplast^Rinterpositional implants, total joint prosthesis with a

Teflon-Proplast^Rfossa and Silastic^RTMJ implants.

[476] The letter goes on to observe:

Practitioners who become aware of device-related deaths, serious illnesses and/or

serious injuries are asked to notify FDA.

And:

The Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other

facilities to report deaths, serious illnesses and injuries associated with the use of

⁵⁴²Ibid at para. 78

Page: 162

medical devices. You should follow the procedures established by your facility

for such mandatory reporting.⁵⁴³

[477] The question that arose was how, or if, Health and Welfare Canada should respond to this

broader concern. The Medical Devices Management Committee met on August 15, 1994. The

mandate of the committee was to review and discuss issues that arose in the context of the

Bureau of Medical Devices. The minutes of the meeting report as follows:

Dr. Magwood described the recent actions of the U.S. FDA with regard to the

problem of Vitek implants. The FDA has recently sent a Dear Doctor letter to

additional professional agencies describing the problems associated with Vitek

implants.

In 1991 the Bureau informed Dental and Maxilla-Facial surgeons [sic] of the

problems associated with the use of the non-compliant devices. However many

calls have been received recently as a result of the wider audience currently

receiving the U.S. FDA information.

Dr. Neufeld responded that the Bureau has the names of 200 professions [sic]

supplied with the devices in Canada prior to 1991. Dr. Tobin requested that an

Alert be drafted and that a mailing list be determined, including these 200

names.⁵⁴⁴

[478] Lindsay Blaney was asked to prepare a communication plan; which she did.⁵⁴⁵Prior to

this plan being completed, the Acting Director, Office of Standards and Regulations, Center for

Devices and Radiological Health, part of the United States Food and Drug Administration wrote

a letter, dated September 24, 1994, to those responsible for medical devices in other jurisdictions,

including Dr. Richard S. Tobin, identified in the minutes of the August 15, 1994 meeting of the

Medical Devices Management Committee as its chairman. The letter was passed on to Lindsay

Blaney by Richard S. Tobin. I quote it in full:

Dear Colleague:

This letter is to alert to our concerns about devices manufactured using Proplast^R,

a composite material consisting of PTFE (polytetrafluoroethylene). We recently

mailed a Public Health Advisory dated July 15, 1994, (copy attached), to

physician’s groups which describes the signs and symptoms of problems patients

have experienced associated with the devices manufactured of Proplast^{R p}.

Proplast^Rwas developed by Charles Homsy, SC. D., for use in

temporomandibular joint (TMJ) devices. We understand Dr. Homsy now resides

in Switzerland and is employed by Promotus S. A., a Swiss medical device

⁵⁴³Exhibit 70 at T. 13

⁵⁴⁴Ibid at T. 14

⁵⁴⁵Ibid at T. 17

Page: 163

manufacturer. We have learned through an article in the London Financial Times,

June 24, 1994, edition (copy enclosed) that Kobe Steel, a Japanese metals

company, is seeking to join with Promotus S. A., who is developing a biomaterial

for bone implants and artificial hip joints using Proplast^R.

We want to bring to your attention our concern over the use of Proplast^Ron any

implant used in a loadbearing situation. Our experience shows that implants made

of Proplast^Rhave been associated with perforation, fragmentation and/or foreign

body response which may result in progressive bone degeneration.

Currently, various implantable devices consisting in whole or in part of Proplast,

Proplast II, or Proplast HA are included on our Import Alert #89 – 10 for

automatic detention, subject to refusal of admission into the United States. A copy

of the Import Alert is provided with this letter.

If you need more information, please contact [name, address and phone number

provided]

Sincerely yours⁵⁴⁶

[479] The Import Alert to which the letter refers put in place an “Automatic Detention”.

Among other products it included:

Temporomandibular Joint (TMJ) Implants

a. Glenoid Fossa

b. Condyle

c. Interpositional Implants⁵⁴⁷

[480] As part of the action taken in response to the information delivered in the letter dated July

15, 1994 (from the Director, Center for Devices and Radiological Health) to the professionals

involved in the implantation and treatment of those receiving temporomandibular joint implants

and the subsequent letter addressed to “Dear Colleague” dated September 24, 1994 (from the

Acting Director, Office of Standards and Regulations), on September 29, 1994, there was the

issuance, by Health and Welfare Canada, of a Canadian Import Alert:

IMPORT ALERT

94-02

SUBJECT:

⁵⁴⁶Ibid at T. 15

⁵⁴⁷Ibid

Page: 164

Implants consisting in whole or in part of any type of Proplast material

manufactured by Promotus S A, Switzerland, or any other manufacturer.

BACKGROUND:

The devices do not have a Notice of Compliance to be sold in Canada.

GUIDANCE:

The product should be refused entry at Customs. Canada Customs have been

asked to detain shipments and call the nearest Health Protection Branch Office.

NAME AND ADDRESS OF IMPORTERS:

At the moment there are no known importers.

COMMODITY:

All implantable devices such as facial, temporomandibular, orthopedic, and

custom implants, as well as blocks and sheets for facial and other reconstruction

labelled as containing or being made of Proplast and being manufactured by

Promotus S A or any other manufacturer are affected by this import alert.

COUNTRY OF ORIGIN:

The manufacturer of these implants is:

Promotus S A

Route de Divonne 48

Nyon, Switzerland.

POTENTIAL PORTS OF ENTRY:

All ports of entry.

SCOPE OF THE ALERT:

National; effective immediately. This alert should remain in force until April 1,

1995. The Health Protection Branch should be consulted before the alert is lifted.

All shipments of these implants, including shipments to hospitals, for professional

use, personal or commercial shipments are subject to this import alert.⁵⁴⁸

⁵⁴⁸Ibid at T. 16

Page: 165

[Emphasis added]

[481] The communications plan developed by Lindsay Blaney first put the circumstances and

situation in context:

Following the 1990 recall, the Health Protection Branch requested the Canadian

Dental Association and the Canadian Association of Oral and Maxillofacial

Surgeons to inform their members of the problems associated with the Vitek jaw

implants and the recommended monitoring of patients.

The priority of the Health Protection Branch in cases such as this is to quickly

remove defective products from the market. The voluntary recall and publication

actions were taken as prudent measures to prevent possible harm from the use and

distribution of the product.⁵⁴⁹

[482] The communication plan outlined seven action items:

1. Prepare an Advisory Letter to Physicians to reiterate the information on the problems

associated with Vitek and other jaw implants and on the recommended procedure for

treatment and monitoring.

2. Request the professional medical journals to print the Advisory Letter to Physicians

3. Make the Advisory Letter to Physicians available to the media on request.

4. Provide patients who have received a Vitek or another jaw implant with an

information package.

5. Prepare a ministerial briefing for release following the broadcast of Marketplace [a

CBC television program] on October 4, 1994.

6. Update Questions and Answers to respond to inquiries from the public and the media.

7. Put in place an import alert on all Proplast implants to prevent their entry in

Canada.⁵⁵⁰

[483] In order to ensure the broadest effort to inform professionals involved, a letter was

prepared and, on October 12, 1994, sent to six professional organizations as follows: (1)

Canadian Medical Association, (2) Canadian Orthopedic Association, (3) Canadian Dental

Association, (4) Canadian Association of Oral and Maxillofacial Surgeons, (5) Canadian Society

of Otolaryngology and Head and Neck Surgery and (6) Canadian Society of Cosmetic and

Plastic Surgery.⁵⁵¹

⁵⁴⁹Ibid at T. 17 at p. 2

⁵⁵⁰Ibid at T. 17 at p. 3

⁵⁵¹Ibid at T. 18

Page: 166

[484] Richard S. Tobin sent a draft of an advisory letter to each of the six organizations to

inform practitioners of concerns which affect patients with alloplastic temporomandibular joint

implants and of recommended monitoring of those patients. The draft letter reads:

Dear Doctor,

Health and Welfare Canada understands that you may see patients who have

received temporomandibular joint (TMJ) implants and wants to communicate this

important information to you.

The purpose of this letter is to inform you of concerns which affect patients with

alloplastic TMJ implants. These implants may fragment, delaminate, or otherwise

be damaged or punctured. Debris in the joint from alloplastic implants can

contribute to progressive bone degenerative changes and to giant cell reaction. All

patients, including asymptomatic patients, should be monitored closely to assure

proper patient care. This monitoring should include clinical and radiographic

examination. The radiographic examination may include transcranial or

tomographic x-rays, CAT scans, bone scans or MRI investigations.

You will find enclosed a copy of the Notice “IMPORTANT INFORMATION

ABOUT TMJ IMPLANTS” recently re-issued by the U.S. Food and Drug

Administration (USFDA) to practitioners who may be involved in the treatment

and follow-up of patients who have received Vitek^RProplast TMJ implants or

other implants such as the Silastic^Rimplant.

Information on the possible complications associated with the Vitek^RTMJ

implants and the recommended monitoring had previously been made available to

all purchasers by the Canadian distributor. In addition, both the USFDA and

Health and Welfare Canada disseminated information to medical and dental

practitioners.

Practitioners who become aware of device related problems are asked to report

the problems to the Director, at the above-mentioned address or phone the toll-

free Hot-Line number 1-800-267-9675. To assist the Department in reaching the

patients who have received alloplastic TMJ implants, we would appreciate if you

would encourage them to contact us at the above address or toll-free Hot-Line

number. Your cooperation in this matter is appreciated.

Sincerely,⁵⁵²

[485] Accompanying the direction and the draft letter (in both French and English) was a

package of material including, in both French and English, the July 15, 1994 letter (to

Orthopedic Surgeons, Otolaryngologists, Plastic and Reconstructive Surgeons from the United

States Food and Drug Administration), the FDA Safety Alert dated December 28, 1990 (also

⁵⁵²Ibid at T. 18 (AGC-05604)

Page: 167

both in French and English), the paper from the American Academy of Oral and Maxillofacial

Surgeons entitled “Recommendations for Management of Patients with Temporomandibular

Joint Implants” and the two notifications which had been printed in the Canadian Dental

Association Journal (the Voluntary Safety Alert of November 23, 1990 and the FDA Safety Alert

of December 28, 1990) as well as the letter to Dr. Gonshor dated September 6, 1991 and

reprinted in the Canadian Association of Oral and Maxillofacial Surgeons Newsletter.⁵⁵³

Although it is not one of the six organizations noted, Daniel Tomlak recalled receiving an alert

from the Royal College of Dental Surgeons of Ontario at some point after his departure from

Thunder Bay.⁵⁵⁴

[486] On October 26, 1994, the Medical Devices Bureau sent the letter and a package of

relevant material to the 182 names from the list of “consignees. The original list of 200

consignees was, by then, a few years old. It was verified for accuracy with the provincial

registrars of dentistry. Some on the original list were no longer in practice. Hence, the reduction

to the 182 to whom the package was sent.⁵⁵⁵

[487] Lindsay Blaney testified that each of the seven action items were undertaken and

completed. Not only was the “Advisory Letter” drafted and sent on to the six professional

associations for distribution to their members, it was accompanied by a direction entitled

“Advisory Letter to Practitioners Re: Temporomandibular Joint Implants” which included the

request that they:

…make this information available to your members via your journal or other

mechanisms in place to disseminate information to your membership”.⁵⁵⁶

[488] It follows, and I accept, that the “Advisory Letter to Physicians” was or would have been

made available to the media, if requested. Thus, of the seven items in Lindsay Blaney’s action

plan, numbers 1, 2 and 3 were satisfied. I should also point out that this was another

circumstance in which Francine Jacques (Gaudette) suggested that a broad group of doctors, in

this case the individual members of each of these organizations, should receive notice of the

identified concerns. A memo from Hripsime Shahbazian dated December 13, 1995 notes, in part:

As well Francine has suggested that the information package sent to the

associations should also be sent to each member of that Association to make sure

that they are aware of this issue.⁵⁵⁷

⁵⁵³Ibid at T. 18

⁵⁵⁴Transcript of Daniel Tomlak (May 21, 2019) at pp. 78-79: It appears that Daniel Tomlak received many notices.

At these pages he said:

….there were so many alerts, warnings and advisories that crossed paths at this time….

⁵⁵⁵Ibid at T. 18 (after the second separator)

⁵⁵⁶Ibid at T. 18

⁵⁵⁷Exhibit 61A at T. 62

Page: 168

[489] As before, the recommendation was not followed. Again, not every idea, or every

suggestion needs to be followed in order to demonstrate that any duty of care, if one is found to

exist, has not been breached. In this case, the whole point was to have the associations, who

would best be able to identify their members, take responsibility for informing them in what they

took to be the best and most responsible way. This is accounted for in the direction which

accompanied the package:

You will find attached an advisory letter to inform practitioners of concerns which

affect patients with alloplastic Temporomandibular Joint Implants, and of

recommended monitoring.

We request that you make this information available to your members via your

journal or other mechanisms in place to disseminate information to your

membership.⁵⁵⁸

And in the draft letter with the salutation “Dear Doctor.” (see para. [484] above).

[490] Lindsay Blaney recounted the work done in preparation for questions that might be asked

of the minister following from the CBC Marketplace interview that was to, and did, take place on

October 4, 1994.⁵⁵⁹This included a document entitled “Background” which was not intended to

be made public but to provide information to those to whom the expected questions could be put.

This document had been updated. There was an earlier version dated September 20, 1994 used to

support an earlier possible question.⁵⁶⁰There was a second version also dated September 20,

1994 although not associated with a particular question.⁵⁶¹There was an even earlier version

dated September 16, 1994 which also appears not to be associated with any particular

question.⁵⁶²It follows that of the seven items in Lindsay Blaney’s action plan, numbers 5 and 6

were dealt with. As already noted, as of September 29, 1994, a Canadian Import Alert was put in

place. Thus, number 7 was also completed.

[491] Of the seven action items this leaves only number 4: “Provide patients who have received

a Vitek or another jaw implant with an information package.” This too was responded to and

from the particular perspective taken, completed. Lindsay Blaney explained that a list had been

made of patients who had themselves or through a surrogate contacted Health and Welfare

Canada regarding TMJ implants. There were 12 of them. Consistent with the communication

plan they were contacted through a letter:

Dear TMJ patient

⁵⁵⁸Exhibit 70 at T. 18

⁵⁵⁹Exhibit 12 at T. 40

⁵⁶⁰Exhibit 71 at T. 20

⁵⁶¹Ibid at T. 10

⁵⁶²Exhibit 70 at T. 19

Page: 169

The purpose of this letter is to inform you of concerns with alloplastic TMJ

implants and provide you with information for proper care and monitoring. You

will find attached documents from various sources on this issue.

Health and Welfare Canada is aware that these implants may break apart,

fragment, and function improperly which may cause the bone to deteriorate.

Symptoms may vary widely, and in some cases, there may be no symptoms even

though the implant is failing. This is why it is especially important for all patients

with a TMJ implant to contact their implanting surgeon and or another

maxillofacial surgeon to schedule a clinical examination and have a Magnetic

Resonance Imaging (MRI) or CT (Computerized Tomography) if they had not

had one within the last six months.

Your name has been added to the TMJ Implant Recipient List for future reference

and to keep you up-to-date on new information that becomes available to the

Department. If you have any further concerns or need more information regarding

this issue, do not hesitate to write to the above-mentioned address or phone the

medical devices problems toll-free Hot-Line number 1-800-267-9675.

Sincerely⁵⁶³

[492] Included with this letter was a document, “Questions and Answers for Patients with

Temporomandibular Implants” meant to supply additional information. There was a further letter

sent to patients. It was dated September 7, 1995 and advised of a settlement which had been

made in a class action in the United States. The implication was that it might be that some

compensation for these Canadian patients was possible and was something that could be

investigated.⁵⁶⁴Accordingly, of the seven action items in the communications plan, number

seven was complied with. All seven were completed.

[493] The question raised is whether the work done, the notice, as given, and the advice

distributed, was insufficient and represented a breach in any duty of care if one is found to have

existed. The Plaintiff says there was such a failure. What is this assertion based on?

[494] One possibility speaks to the relationship between Health and Welfare Canada and the

United States Food and Drug Administration. On the one hand, were the findings of the latter

relied on too easily by the former? Did the foundation of the decisions made by the United States

Food and Drug Administration justify the subsequent acceptance of them, and reliance on them,

by Health and Welfare Canada when, for example Notices of Compliance were granted to Block

and Sheeting? On the other hand, were there situations where Health and Welfare Canada did not

accept or act on actions proposed and undertaken by the American authorities, for example the

decision to directly notify all doctors and surgeons? Should they have been? Is the failure to do

so demonstrative of a failure to respond to any duty of care that could be said to exist? I observe

what seems clear. These two perspectives stand in opposition to each other. The idea that the

⁵⁶³Ibid at T. 19

⁵⁶⁴Ibid at T. 21

Page: 170

actions of Health and Welfare Canada can be parsed such that in some cases the determinations

of the United States Food and Drug Administration should not have been accepted when they

were and others followed when they were not may, in some theoretical place, seem correct. In

this situation, evolving as it did over time, the idea that the people involved at the time (as

opposed to those with the uninhibited view of hindsight) should have seen this divergent path

(following the FDA in some circumstances and not others) as the reasonable route to satisfying a

possible duty of care is problematic. There is nothing intrinsically wrong with considered

adherence to what has taken place in the United States, it just should not be blind adherence. In

this case, having examined the Submission, and with confirmation from his superiors, Richard

Lawuyi, sought advice from the United States Food and Drug Administration as to how they had

proceeded. He recommended the same approach. The recommendation was accepted. When it

came to advising all doctors, consideration was given to what was happening in the United

States, the differences in Canada identified and a different conclusion adopted.

[495] It should not be surprising that the Canadian representatives and their American

counterparts were in contact and communication as the concerns for alloplastic implants, in

general, and specifically those that utilized Proplast, developed. This is a mark of bureaucratic

common sense. Why would we duplicate what has already been done? This is particularly so

when consideration is given to the magnitude of the problem in the United States as compared to

its scale here. A news release from the Department of Health and Human Services, dated

October 2, 1991 provided an indication of the number of these implants distributed in the United

States:

The implants were used to treat temporomandibular joint syndrome, or TMJ, a

painful condition of the joint that connects the jaw and the skull. At least 26,000

implants were distributed to doctors and hospitals, but the agency does not have

data on how many patients have them.⁵⁶⁵

[496] It was possible that many more were implanted:

An estimated 200,000 patients have received alloplastic TMJ implants

nationally.⁵⁶⁶

[497] This is to be compared to the understanding that the sole Canadian distributor

(Instrumentarium Inc.) reported that 207 units utilizing Proplast were imported and that

following its recall there were 162 that may have been implanted.⁵⁶⁷For the Americans this was

a bigger problem with broader ramifications. The United States has a larger population and, as a

general notion, more resources to apply to its solution.

[498] This plays a role in how the situation developed. The evidence shows that over time those

responsible, in Canada, felt the need for and sought greater resources; more people and more

money. The field of medical devices grew more quickly than anyone had predicted. In a

⁵⁶⁵Agreed Statement of Facts at footnotes 56 and 57 and Exhibit 70 at T.5

⁵⁶⁶Ibid at footnote 51 (Retrieval Analysis Study at p. 1)

⁵⁶⁷Exhibit 70 at T. 3

Page: 171

memorandum dated May 18, 1990 entitled “Discussion Draft-Priority Setting and Future Plans

for Medical Devices Pre-Market Review” to E. G. LeTourneau, Director Bureau of Radiation

and Medical Devices, W. J. Welsh Chief, Pre-Market Division, Bureau of Radiation a Medical

Devices observed:

As of March 1990 there were approximately 144,000 entries in the database

representing approximately 477,000 devices offered for sale by 3,516

manufacturers and 3,400 distributors. Approximately 25,000 devices were added

in 1989-90. The database is a reference source for purchasers of medical devices,

Field Operations personnel, provincial health authorities, problem reports, recalls

etc.⁵⁶⁸

[499] The demand for expeditious review grew with the demand for new devices. The

manufacturers wanted to bring their products to market and health professionals and regulators

wanted to assist those who needed treatment by allowing the sale of medical devices that would

help relieve those patients. The memorandum referred to immediately above goes on, and under

the heading “Inadequacies of the Present Program”, notes in part:

The present Part V program does not provide an acceptable service to

manufacturers. Submission processing and delays are unpredictable because of

staff turnover and inadequate numbers of trained personnel. Over two thirds of the

submissions are not responded to within the 60 day regulatory time limit. Because

of the numbers of submissions and inadequate resources, in-depth scientific

reviews often are not possible. On average, only 20-25 hours can be allocated to

the review of a submission or package of additional information.

The present Part V program does not provide an acceptable service to the

Canadian consumer. Because of the inadequate resources, many high-risk devices

and devices of unknown risk are not subject to pre-market review. Contrary to

public belief there is no review of device notifications to monitor manufacturers

labelling for safety and effectiveness claims. A device can be on the market for 10

days before the Branch becomes aware of its existence. There is no regulatory

involvement or scientific review unless there is a problem report or recall.

Approximately 95% of the medical devices being offered for sale in Canada do

not undergo pre-market or regulatory scrutiny.⁵⁶⁹

[500] Beyond money and people other administrative responses were needed. One of them was

the March 8, 1988 memo of W. J. Welsh to which I have already referred:

⁵⁶⁸Exhibit 49 at T. 9

⁵⁶⁹Ibid (The evidence of Nancy Shadeed and Dr. Richard Lawuyi makes clear that the submissions made in respect

of Proplast products were the subject of review.)

Page: 172

In an attempt to speed-up the pre-market process, the following modifications are

being implemented.⁵⁷⁰

[501] One of the means used to expedite the process was the recognition of the usefulness of

accepting as evidence the work that had been undertaken by the United States Food and Drug

Administration. This was recognized in the recommendations forthcoming from a meeting of the

Advisory Committee on Medical Devices that took place on October 25 and 26, 1988:

Recommendation No. 5:

The Bureau is encouraged without changing its regulations but via an internal

working arrangement, to accept evidence of F.D.A. approval as Bureau

acceptance of pre-market review application.

[502] Again, this was to be considered, not blindly accepted:

In cases of simultaneous application for pre-market review, the Bureau is to use

its own discretion as to the procedures to follow.⁵⁷¹

[503] The memorandum (November 9, 1988) from W. J. Welsh A/Chief, Pre-Market Division

to Dr. E.G. LeTourneau, Director, Bureau of Medical Devices demonstrates that this

recommendation was followed:

The only recommendation arising out of the October 25-26, 1988 meeting of

relevance to the Pre-Market Division is Recommendation No. 5. As you are

aware, we have, since last spring, been following this suggestion. Part V

submissions for devices which have FDA PMA approval are processed with

minimum delay.⁵⁷²

[504] I point out that the process of review undertaken by Richard Lawuyi was consistent with

this approach. He received the submissions made in support of the issuance of Notices of

Compliance. He reviewed them as best as he could in the circumstances. In the end he felt it

would be helpful and sought and obtained instructions to consult with the United States Food and

Drug Administration. He recommended that the conclusion adopted there be implemented here.

[505] Doran Ryan, the American maxillofacial surgeon, used Vitek TMJ Proplast implants

from 1983 but stopped in 1985. He was cross-examined by counsel for the Plaintiff. He

acknowledged his reliance on the acceptance, by the United States Food and Drug

Administration, of Vitek Proplast TMJ implants for use in treating patients. He did this

understanding that the approval was based on a submission made pursuant to the 510K process.

⁵⁷⁰Exhibit 12 T. 31

⁵⁷¹Exhibit 49 at T. 31 and para 239 a bove

⁵⁷²Ibid at T. 4

Page: 173

Under this approach the manufacturer could obtain entry to the market by demonstrating that the

“new device” was “substantially equivalent” to one already being used. There was no reliance,

by the regulator, on studies demonstrating the “safety and efficacy” of the product. It was

suggested that this was not, at the time, a regulatory requirement in the United States.

Q. Okay. And so, the predicate device, as I understand it, maybe have preceded a

point in time at which the FDA was even in the business of reviewing safety and

efficacy?

A. It could be. I don't know that. I don't know.⁵⁷³

[506] The implication was that, in the absence of evidence of safety and efficacy, the Canadian

regulators had erred in relying on the American authorization. I do not accept this assertion. It

seems self-evident that the foundation behind the 510K approach used by the United States Food

and Drug Administration is that the safety and efficacy are sufficiently demonstrated by the

presence in the market of the product that is “substantially equivalent” to the devices for which

access to that market is being sought. Why do more tests when the required result has already

been demonstrated by the acceptance and use of a similar product? In this case, it was based on

the use of “silastic implants” in joints other than the jaw:

I think they went on the history of the silicone implants in other joints, using

fingers and other places. It was used to prevent joints from healing together

causing ankylosis. That's what I understood about the silicone implants and what

the FDA's thought was on the use of silicone implants. Other than that I don’t

know what their standard was in determining whether a product was safe.⁵⁷⁴

[507] Doran Ryan agreed that in an acceptance, as provided by the United States Food and

Drug Administration, there is a measure of risk. Counsel for OHIP, in questioning Doran Ryan

wondered whether or not the United States Food and Drug Administration would have

undertaken a risk assessment.⁵⁷⁵I do not believe it is outside the proper application in my role to

note it is difficult if not impossible to objectively assess risk of the unknown, for example: the

body’s response to a new treatment. I repeat we are balancing efficacy (our desire to help those

in pain) against safety (will we harm rather than help them). Whether where any particular

medical device may fall between these two ends leaves it as appropriate for the issuance of a

Notice of Compliance is a matter of discretion for the responsible regulator. It may be that there

is something that can be learned from the experience with earlier and other efforts. That is the

proposition behind the form 510K approach.

⁵⁷³Transcript: Cross-Examination of Doran Ryan (June 4, 2019) at p. 5 (Later in his examination I proposed to

counsel for the plaintiff that Doran Ryan had said that at the time there was no requirement for the United States

Food and Drug Administration to look at safety and efficacy. Counsel agreed (see: p. 12). It would seem we were

both wrong.)

⁵⁷⁴Ibid at p. 7

⁵⁷⁵Ibid at pp. 7-8

Page: 174

[508] In Canada there is a similar but not identical process. This was “grandfathering”, to

which I have already referred. This encompassed the idea that if a medical device was sold in

Canada prior to the regulatory amendments made effective on April 1, 1983 its sale and use

would be allowed to continue. There was evidence to show that those supporting the utilization

of Vitek Proplast devices claimed that such sales had taken place and that they should be

recognized as “grandfathered”. This was not accepted in either 1987 or 1988. The submissions

made were based on the understanding that the post-1983 regulatory scheme applied. Within the

trial the Crown acknowledged that no reliance was being placed on any supposed prior sales and

that the idea of “grandfathering” was not available as a means of exculpating it (the Crown) from

any failure to follow the requirements of the post-1983 regulatory scheme, in particular the need

to be satisfied of the “safety and efficacy” of the device in issue.

[509] The issue remains whether there was a breach of this requirement evidenced by the

acceptance of advice from the United States Food and Drug Administration in circumstances

where its acceptance of Vitek Proplast products was based on a 510K submission. The fact

remains that the medical devices, brought forward by Vitek Inc., that were dedicated TMJ

implants (Proplast TMJ Interpositional Implants, Proplast TMJ Condylar Prosthesis, Type VK

and Proplast TMJ Fossa Prosthesis, Type VK) were not granted Notices of Compliance. It is

only “Block and Sheeting” that were recognized in this way. I repeat my determination that this

was not an authorization that foresaw the use of Block and Sheeting as TMJ implants. It did not

accept those “devices” for this kind of orthopaedic use.

[510] Even so I should point out that Doran Ryan was asked whether further studies should

have been done. In particular he was asked whether the United States Food and Drug

Administration “should have done a safety assessment before allowing Proplast-Teflon be

implanted into the jaw”.⁵⁷⁶The question presupposes that it was the regulatory scheme active in

the United States that made it the responsibility of the regulator (the United States Food and

Drug Administration) to undertake these studies. There is nothing to suggest this was the case.

Moreover, there is no indication what a “safety assessment” would be. For myself, I find it

difficult to distinguish the concept of a “safety assessment” from a “risk assessment” as

discussed above. The regulation requires a balancing of “safety” against “efficacy”, not the

treatment of safety as a single consideration. The answer of Doran Ryan to the question that was

asked is apropos:

I think that they should have, and Proplast Teflon should have had better studies

to show that it was safe and effective. I'm not sure it's the FDA's position to do

those studies. They rely on the companies to provide those studies so that they

can evaluate. I think they probably could have used some more evaluation from

Vitek before they approved that product.⁵⁷⁷

[511] Doran Ryan went on to acknowledge that there were studies that had been done by Vitek:

⁵⁷⁶Ibid at p. 9

⁵⁷⁷Ibid at pp. 9-10

Page: 175

Q. And, Dr. Ryan, you are generally familiar with the studies that were done by

1983 on Vitek Proplast TMJ?

A. Generally. I know they did some bench studies on the joint, and they looked

at wear particles that were produced, and the amount of wear particles based on

that assumption that 20 pounds of pressure on a joint at any given time. I was

aware that they had done some bench studies on the product at Vitek.⁵⁷⁸

[512] Doran Ryan summarized the basis for his acceptance and use of Vitek Proplast as a

suitable component of TMJ implants:

Q. Okay. Sorry, Your Honour. I'll start again. Is it fair to say that the bench

testing wouldn't satisfy you as to safety or efficacy; correct?

A. At the time that I implanted, I was satisfied with the testing, relying on the

FDA. Also, that they approved the product, and the nine-year history they had

with it. I'm not a scientist. I'm a surgeon.⁵⁷⁹

[513] The reference to a nine-year history is a citing of the Kiersch study which I have already

noted (see paras. [156-157] above).⁵⁸⁰

[514] It is not for me to look behind the work done by the United States Food and Drug

Administration in allowing for the sale and use of Vitek Proplast products. It is whether the

taking note of that conclusion and any consequential reliance on it by Health and Welfare

Canada was reasonable or, to the contrary, was demonstrative of a failure of any duty of care if

one is found to exist. In the circumstances I find that to the extent of it, any reliance placed on

the treatment of the Vitek TMJ Proplast implants by the United States Food and Drug

Administration was appropriate. In recommending that Block and Sheeting be given Notices of

Compliance and that inter-positional implants, TMJ Fossa Prosthesis, Type VK and TMJ

Condylar Prosthesis, Type VK not be, Richard Lawuyi did more than just telephone the United

States Food and Drug Administration and then do what it had done.

[515] This takes me to the other side of the equation: the proposition that there were actions

undertaken by the United States Food and Drug Administration that were not replicated by the

Canadian authorities when they should have been and that the failure to do so was a breach of the

duty of care if one is found to exist. For the most part this assertion refers to (1) the recognition

that the concerns raised were not just with respect to interpositional implants but to all Proplast

products including Proplast TMJ Condylar Prosthesis, Type VK and Proplast TMJ Fossa

Prosthesis, Type VK, and (2) the various suggestions made by the United States Food and Drug

⁵⁷⁸Ibid at p. 10

⁵⁷⁹Ibid at p. 11

⁵⁸⁰For ease I repeat the citation for the study done by Kiersch: “Kiersch TA. The use of Proplast-Teflon implants for

meniscectomy and disc repair in the temporomandibular joint [Abstract]. Presented at the AAOMS Clinical

Congress on Reconstruction with Biomaterials, San Diego, 1984”.

Page: 176

Administration that efforts be made to notify all physicians and dentists who had purchased or

implanted Vitek TMJ Proplast implants. Both occurred after:



the March 23, 1990 Voluntary Safety Alert issued by Vitek, Inc. which included a

request that all unused implants be returned for a credit



the December 28, 1990 FDA Safety Alert, and

the recall of January 7, 1991 by the United States Food and Drug Administration.

[516] The first two of these were directed to the physicians (“Dear Doctor”, “To Oral and

Maxillofacial Surgeons”). The third was announced by way of a news release dated January 8,

1991 which advised of the recall and the concerns related to the Vitek products. It gives no

direction as to who was to be notified.

[517] It identifies the products first, as “certain jaw implants” but subsequently as:

The devices known as interpositional implants, were manufactured by Vitek, Inc.

of Houston Texas.

And

About 26,000 of the Vitek interpositional implants were distributed. It is not

known how many were implanted in patients. ⁵⁸¹

[518] Having learned of the firm-initiated recall on May 16, 1990, Health and Welfare Canada,

the next day, sent the “Information of Potential Recall” to the Medical Devices Unit in the

Central Region. By August 3, 1990 Health and Welfare Canada was aware that four doctors had

received the implants and on August 20, 1990 the Instrumentarium Inc. recall was initiated.

Consistent with the approach in the United States the instructions to “All Instrumentarium

Agents” was to “make sure that every physician having used these items are made aware of this

situation”. The recall suggested that “you leave a copy of the notification letter behind with each

of the physicians involved.”⁵⁸²Similarly, in Canada, the substance of the recall was in keeping

with the action taken in the United States. The August 20, 1990 recall was a “voluntary recall”

instituted not by the manufacturer, Vitek, Inc. but by the distributor, Instrumentarium Inc. Any

apparent delay was caused by the fact that for whatever reason, Instrumentarium Inc. had not

been made aware, by Vitek, Inc. of its recall in the United States. This was recognized in the

letter signed by Francine Jacques (Gaudette), as Inspector, Medical Devices Unit on August 23,

1990 to Richard Vincent, CEO, of Instrumentarium Inc:

Dear Mr. Vincent:

⁵⁸¹Exhibit 70 at T. 5 and at T. 11D

⁵⁸²Agreed Statement of Facts at para. 116 and the footnoted documents including Exhibit 70 at T. 11B

Page: 177

This letter is to follow up on our visit of August 21, 1990, regarding the recall of

all lots of Vitek temporomandibular joint (TMJ) interpositional implants (IPIs).

The catalogue numbers involved in Canada are 912.71, 912.72 and 912.74.

It appears that you had not received the communication from Vitek and that we

informed you of this recall during our telephone call on August 16, 1990…

[519] In Canada, insofar as notifications were concerned, Instrumentarium Inc. directed its

agents to contact the “physicians” involved. It is not accurate to suggest that the Canadian

authorities did not demonstrate an interest in the broader range of Vitek TMJ Proplast products.

The letter to Richard Vincent of August 23, 1990 (three days after the Canadian voluntary recall

was initiated) notes:

Section 34 of the Medical Devices Regulations allows the sale of a new device

only if the manufacturer of the product has received a notice of compliance.

Therefore, during our visit, you agreed to the voluntary detention of all Vitek and

Novamed Proplast implants for which a notice of compliance had not been

issued.⁵⁸³

[520] The letter then lists the Catalogue No.’s, the Quantity (Units) and Value ($) of the

products that were detained. The list includes Catalogue No’s: 813.16 and 813.17 (both examples

of Proplast HA/UPE TMJ Fossa Prosthesis, Type VK’s), as well as, 813.61, 813.67 and 813.68

(each an example of Proplast HA TMJ Condylar Prosthesis, Type VK’s). This stands as an

example of Health and Welfare Canada looking beyond the actions in the United States. This

occurred in the context of the recall commenced on August 20, 1990 and follows on from one of

the inspections undertaken by Francine Jacques (Gaudette).

[521] The notice that followed was the republication of the March 23, 1990 Vitek, Inc.

Voluntary Safety Alert which appeared in the Canadian Dental Association Journal⁵⁸⁴(April

1991 Vol. 57 No. 4). It was introduced by a letter published on the preceding page of the journal:

The Health Protection Branch (HPB) wishes to ensure that every dental surgeon

concerned is made aware of the following Voluntary Safety Alert issued by Vitek

Inc. in 1990.

In Canada, the Vitek Temporomandibular Joint (TMJ) and Interpositional Implant

(IPI) were imported and distributed by Instrumentarium….

[Emphasis by underlining and italics added]

⁵⁸³Ibid at para. 117 and at Exhibit 61A T.24) as well as Exhibit 59 T. 49 (English translation)

⁵⁸⁴Exhibit 70 T. 10

Page: 178

[522] The presence of “Vitek Temporomandibular Joint” separate from the identification of

“Interpositional Implant” but joined by the conjunction “and” suggests a concern for more than

just “interpositional implants”. The reference to “Vitek temporomandibular joint” demonstrates a

broader concern that extends to other Vitek products. This extension is recognized in the further

republication, this one of the FDA Safety Alert dated December 28, 1990. It appeared in the

Canadian Dental Association Journal⁵⁸⁵(April 1991 Vol. 57 No. 8) and was introduced as

follows:

Health Protection Branch Issues Second Alert

The Operations of Compliance Division of the Health Protection Branch, Health

and Welfare Canada, has issued a second alert-the first was published in the April

1991 issue of the CDA Journal-regarding the Vitek Temporomandibular Joint and

Interpositional Implants….

[Emphasis by underlining and italics added]

[523] This is the same wording and separation of concerns, the first for “Vitek

Temporomandibular Joint” Implants and the second for “Interpositional Implants”. That this

concerns separate product types of implants is underscored by what the introduction says after it

identifies the manufacturer and distributor of those products:

Both have been associated with fragmentation and/or a foreign body response.

[Emphasis added]

[524] This continues the Canadian interest in products beyond Interpositional Implants at a time

before this concern was expressed by American authorities.

[525] The third republication, this one in the November 1991 issue of the Canadian Association

of Oral and Maxillofacial Surgeons Newsletter⁵⁸⁶is ambiguous. The letter being published was

authored in Canada, not in the United States. It refers only to “Interpositional Implants” as the

heading but uses broader language in the succeeding substantive sentence:

Interpositional Implants

The legacy of the Vitek temporomandibular joint prosthesis continues, although

the company and the product are no longer around…

[Emphais added]

⁵⁸⁵Ibid

⁵⁸⁶Ibid

Page: 179

[526] As we have seen the term “Interpositional Implants” may refer to a specific type of

prosthesis but is also used in a generic fashion attributable to all devices used to replace or

augment the meniscus between the fossa and the condyle.

[527] In the period following the recalls, the United States Food and Drug Administration

began to show interest and concern for Vitek Proplast products beyond TMJ implants. The

Public Health Advisories issued by the United States Food and Drug Administration during

September 1991 addressed the broader array of Vitek TMJ Proplast implants and sought to have

the patients who had received them identified, examined and monitored. The Agreed Statement

of Facts notes that the article which appeared in the “Medical Devices Bulletin” during October

1991, made the statement that on October 2, 1991 patients with Vitek TMJ Interpositional

Implants had been advised, by the United States Food and Drug Administration, to be examined

and monitored. The Medical Devices Bulletin says exactly that:

On October 2, FDA advised patients with certain jaw implants manufactured by

Vitek, Inc. of Houston to be reevaluated by their oral and maxillofacial surgeons

or dentists to determine whether the implants are breaking down or causing bone

degeneration.

[528] It also says that the United States Food and Drug Administration was taking

responsibility for notifying these patients:

FDA is taking responsibility for alerting patients, since Vitek, Inc., which was

ordered to notify oral and maxillofacial surgeons, is bankrupt. The devices were

manufactured by Vitek from 1973 through 1988.

[529] And that in furtherance of taking on this responsibility the United States Food and Drug

Administration was establishing a program to undertake this notification:

FDA is establishing a notification program for patients with the Vitek implant,

which will be operated by Medic Alert, a nonprofit foundation. Oral and

maxillofacial surgeons who have implanted the devices, dentists treating patients

with the devices, or patients who have the implants are urged to call 800-554-

5297 for further information.⁵⁸⁷

[530] What the Medical Devices Bureau does not explain is what was done on October 2, 1991

to “advise patients…to be reevaluated.” It appears to be nothing more than issuing the “Medical

Alert”⁵⁸⁸and issuing a press release⁵⁸⁹on that day. There is nothing that directs or purports to

deliver either of these documents to patients. The latter is “For Immediate Release” but does not

say to who. It states what is repeated in the Medical Alert Bulletin; that the “Food and Drug

Administration today advised patients with certain jaw implants…to obtain an immediate

examination” and that it was “taking responsibility for alerting patients.” Presumably, it is

⁵⁸⁷Agreed Statement of Facts at para. 70

⁵⁸⁸Ibid at para. 71

⁵⁸⁹Ibid at para. 71

Page: 180

referring to the former document (the Medical Alert) but while this document is entitled FDA

Notifies Physicians and Patients About Risks of TMJ Implants and while it indicates that a toll-

free number had been established to advise health professionals and patients about risks

associated with temporomandibular join implants manufactured by Vitek Inc., there is nothing

that explains how this had been, or how it was to be, brought to the attention of the patients.

[531] The difficulty in doing this was noted in the press release:

At least 26,000 implants were distributed to doctors and hospitals but the agency

does not have data on how many patients have them.

[532] I review this because in comparing the response of Health and Welfare Canada to the

concerns and actions of the United States Food and Drug Administration, it is important to

understand what the American regulators did with respect to their increased concern for the

broader range of products and the patients involved. By the end of October, 1991, it had done

nothing beyond issuing Public Health Advisories, publishing an article in its Medical Devices

Bulletin, issuing a Medical Alert and an accompanying press release. No direct action was taken

to identify or get in touch with patients. All that followed in the United States during the

succeeding years were more Bulletins (December 1, 1991), Alerts (May 29, 1992, Advisories

(August 1992/redistributed July 1993) and articles (October 1993 based on a workshop that had

taken place in November 1992). Finally, there was the letter of July 15, 1994 to: “Orthopedic

Surgeons, Otolaryngologists, Plastic and Reconstructive Surgeons and the letter of September

24, 1994 from the American authorities to, among others, Dr. Richard S. Tobin. The Canadian

response was in line with and similar to that of the United States. An Import Alert was issued,

the seven point communication plan was prepared and acted on, including the preparation of a

letter to be sent to six professional associations whose members would be aware of patients who

had received these implants, a package to be delivered to the patients who had or would be

identified, as well as media messaging from politicians and bureaucrats.

[533] In cross-examination Lindsay Blaney was asked how it could be that the Canadian

response had not been stronger and more vociferous. There were suggestions that it should have

been but these were rejected by those responsible. Lindsay Blaney was careful to explain how

the Canadian situation was different from that of the United States. There it was understood that

26,000 of the implants of concern had been distributed. There was no certainty as to how many

had been implanted and no way of identifying exactly who the recipients were. It was understood

that the American recall had not been a success⁵⁹⁰whereas the one in Canada was complete.⁵⁹¹

Only 162 of the implants had been identified as having been used in Canada.

⁵⁹⁰Exhibit 49 at T. 11, Exhibit 59 at T. 42 (Memorandum dated August 3, 1990 R. W. Scales A/Medical Device

Specialist to Benoit Toupin Supervisor):

Follow-up with the FDA in Dallas on August 2 indicated that the manufacturer, Vitek Inc., had

filed for bankruptcy and was in receivership. Their investigation is continuing into the matter

due to possible inadequacy of the recall.

Page: 181

[534] In the circumstances, whether it be the acceptance of the advice provided by those at the

United States Food and Drug Administration or the supposed failure to respond to that advice in

an appropriate manner, I am unprepared to accept that the use of and adherence to that advice by

the officials at Health and Welfare Canada was anything other than considered, appropriate and

reasonable in the circumstances and certainly not demonstrative of any breach of any duty of

care, if one is found to exist, as between the Crown and the members of the class.

[535] To my mind it seems clear that interaction between the responsible individuals and

agencies in different countries and jurisdictions is advisable and should be beneficial. There is

evidence that co-operation is active in the field of Medical Devices:



The 1988 version of the program for “Inspection of Manufacturers, Importers and

Distributors of Medical Devices” includes an encouragement to Canadian

industry to use the United States Food and Drug Administration approach and

Guidelines in addressing good manufacturing practices.⁵⁹²



There is an international registry of patients involved with these implantable

devices.⁵⁹³

On May 28, 1991 there was the tripartite meeting involving representatives from

the United States Food and Drug Administration, Health and Welfare Canada and

the United Kingdom’s Department of Health and Social Security.⁵⁹⁴



On October 28, 1991, the United States Food and Drug Administration informed

foreign regulatory agencies of Vitek TMJ IPI device sales within their countries

and remedial measures that the United States Food and Drug Administration had

taken.⁵⁹⁵

The letter of September 14, 1994 sent by George A. Brubaker, Acting Director,

Office of Standards and Regulations, Center for Devices and Radiological Health

to “Dear Colleague” in this case being Richard S. Tobin.⁵⁹⁶

⁵⁹¹Agreed Statement of Facts at paras. 117, 118 and 119

⁵⁹²Exhibit 59 at T. 38

⁵⁹³Agreed Statement of Facts at para. 73:

The Medical Bulletin issued on December 1, 1991 provided information on how to enroll in the

international patient registry.

⁵⁹⁴Agreed Statement of Facts at para. 67

⁵⁹⁵Agreed Statement of Facts at para. 72

⁵⁹⁶Exhibit 70 at T. 15

Page: 182

[536] The interaction between the United States Food and Drug Administration and Health and

Welfare Canada was demonstrative of this interrelationship and, so far as I can see, was a benefit

to all. The efforts of Health and Welfare Canada are more than enough to respond to the narrow

assertion of Doran Ryan referred to in the Submissions of the Plaintiff that it was important to

inform all patients that the implants they had received had been recalled.⁵⁹⁷

ANALYSIS

[537] I return to what was said at the beginning of these reasons. The search for the balance

between private and public responsibility is a difficult one. It has been the subject of some

relatively recent consideration. This case is founded in negligence. The common issues that arise

from its certification as a class action are tied to the tests that consider whether negligence is

proved. The law talks in terms of the presence of a “private” duty of care. The courts are used to

applying the approach that originates in the case of Anns v. Merton London Borough Council.⁵⁹⁸

That case has been set aside in the United Kingdom but continues to be relied on in Canada,

adopted and adapted by cases like Cooper v. Hobart⁵⁹⁹and Kamloops (City of) v. Nielsen.⁶⁰⁰The

Submissions of the Plaintiff and the Submissions of the Defendant both make brief reference to

Paradis Honey Ltd. v. Canada (Attorney General).⁶⁰¹In the Submissions of the Plaintiff the

reference is in only one paragraph. In the Submissions of the Defendant it is a reference in a

footnote.⁶⁰²That case recognizes the broad distinction between how private and public activity is

treated by the common law:

…By and large, our common law recognizes the differences between private and

public spheres and applies different rules to them. Private matters are governed by

private law and are addressed by private law remedies; public matters are

governed by public law and are addressed by public law remedies. This has

become a fundamental organizing principle: Dunsmuir, above; Canada (Attorney

General) v. Mavi, 2011 SCC 30 (CanLII), [2011] 2 S.C.R. 504; Air

Canada v. Toronto Port Authority, 2011 FCA 347 (CanLII); [2013] 3 F.C. 605.⁶⁰³

[538] The case proposes that the private law (negligence) is not the only way, perhaps not the

preferable means, to assess any tort or fault alleged against a public official or agency acting in

the name of the Crown:

At the root of the existing approach is something that makes no sense. In cases

involving public authorities, we have been using an analytical framework built for

private parties, not public authorities. We have been using private law tools to

⁵⁹⁷Submissions of the Plaintiff at paras. 46 and 50

⁵⁹⁸[1977] UKHL 4, [1978] AC 728

⁵⁹⁹2001 SCC 79 (CanLII), [2001] 3 SCR 537, [2001] SCJ No 76 (QL), [2001] CarswellBC 2502, 206 DLR (4th)

193, [2002] 1 WWR 221, 261 WAC 268, 96 BCLR (3d) 36

⁶⁰⁰1984 CanLII 21 (SCC), [1984] 2 SCR 2, [1984] CarswellBC 476, [1984] SCJ No 29 (QL), 54 NR 1, 10 DLR

(4th) 641, [1984] 5 WWR 1, 66 BCLR 273, 11 Admin LR 1, 29 CCLT 97

⁶⁰¹2015 FCA 89 (CanLII), [2016] 1 FCR 446, [2015] FCJ No 399 (QL), 382 DLR (4th) 720

⁶⁰²Respectively paragraph 484 and footnote 477

⁶⁰³Paradis Honey Ltd. v. Canada (Attorney General), supra (fn. 601) at para. 129

Page: 183

solve public law problems. So to speak, we have been using a screwdriver to turn

a bolt.⁶⁰⁴

[539] The decision of the majority suggests that it is time for public law principles to be applied

and where appropriate used as the foundation for monetary damages. On the one hand: “A claim

for monetary relief in public law is novel”⁶⁰⁵On the other hand “Nothing obstructs this. In

particular, the traditional rules of Crown immunity and the Crown Liability and Proceedings

Act⁶⁰⁶and its predecessors have not prevented the granting of monetary relief in public law

cases…”⁶⁰⁷

[540] The tool offered by public law is judicial review. When the action of the Crown is outside

the boundaries of what the authorities dictate, the court will proceed to move to the question of

remediation, the remedy. In an application for judicial review remedies are discretionary:

This framework – the unacceptability or indefensibility in the administrative law

sense of the public authority’s conduct and the court’s exercise of remedial

discretion – should govern whether monetary relief in public law may be had by

way of action.⁶⁰⁸

[541] While Paradis Honey proposes a different approach; it is not much help here. The

decision reflects on a motion to strike the Statement of Claim as disclosing no reasonable cause

of action. The conclusion was that it was not plain and obvious that the action could not succeed.

The final decision on whether the plaintiff would succeed awaited trial. In the case before this

court we have had the trial. The evidence demonstrates that the understanding of the impact of

Proplast on the condition of those who received the implants evolved over time. The decision of

whether a product was to be granted a Notice of Compliance contains a large measure of

discretion. (Where did the product fall in the balance between safety and efficacy?) None of the

devices directed specifically for use as temporomandibular joint implants were issued Notices of

Compliance. Only those intended for a broader, more general intended usage were taken to have

established a balance that supported granting the permission to enter the market. It was still for

⁶⁰⁴Paradis Honey Ltd. v. Canada (Attorney General), supra (fn. 601) at para. 127

⁶⁰⁵Paradis Honey Ltd. v. Canada (Attorney General), supra (fn. 601) at para. 116

⁶⁰⁶R.S.C. 1985, c. C-50

⁶⁰⁷Paradis Honey Ltd. v. Canada (Attorney General), supra (fn. 601) at para. 140 citing Roncarelli v. Duplessis

[1959] S.C.R. 121, 16 D.L.R. (2d) 689 and McGillivray v. Kimber (1915), 1915 CanLII 608 (SCC), 52 S.C.R.

146, 26 D.L.R. 164 and at para. 131:

In McGillivray v. Kimber (1915), 1915 CanLII 608 (SCC), 52 S.C.R. 146, 26 D.L.R. 164, the

Supreme Court granted monetary relief and, in so doing, did not invoke negligence principles or

any other nominate cause of action in private law. And in Roncarelli, above, the Supreme Court

(per Justice Rand at page 142) granted monetary relief, relying not only on negligence

(then article 1053 of the Civil Code of Québec) but also on “the principles of the underlying

public law.”

⁶⁰⁸Paradis Honey Ltd. v. Canada (Attorney General), supra (fn. 601) at para. 127 at para. 139

Page: 184

the surgeon to decide if or how to use them. Once the difficulties were discovered, there were

inspections and a wide set of notices distributed.

[542] As it is the Plaintiff does not seek monetary damages through reliance on public law

principles:

In the unique facts of this case, a public law remedy would be appropriate. What

the plaintiff class is seeking is a mandatory order compelling the Ministry of

Health to correct the record, and to inform Canadians that certain Proplast devices

had been approved by Health Canada, were likely implanted into a number of

Canadians, and had never been recalled by Health Canada.⁶⁰⁹

[543] This request does not comport with the evidence as I have understood it. Much effort was

made to inform Canadians. Those efforts have been undertaken considering the situation as it

developed, keeping in mind the Canadian circumstances. There is little, if any, evidence to

suggest that there were any relevant health professionals who did not receive notice. A remedy at

public law is discretionary. Surely, that discretion requires some consideration of the purpose

and utility of the proposed relief. In this case the Court is being asked to compel notice in respect

of devices that were either not granted Notices of Compliance or, where Notices of Compliance

were issued despite the fact that there is not a demonstrated case of any of those devices (Block

or Sheeting) having been used as temporomandibular joint implants. No surgeries implanting any

of these devices (including those not issued Notices of Compliance) took place after 1990, at

which time the products were removed from the market. The size of the class was recognized by

the Superior Court as long ago as 2007 as likely being smaller than the 2,600 suggested by the

Plaintiff (“the class might not exceed 200 persons”).⁶¹⁰The only justification for the higher

number was its relationship to the stated number of these implants used in the United States. The

Court of Appeal in 2012 came to the conclusion that the class was “a relatively small group of

consumers”.⁶¹¹If I were required to, I would exercise my discretion against such a remedy.

There is little to be gained from a notice this long after the events that led to this litigation. There

is no “record to correct”.

[544] As it is, the discretionary nature of the decisions made, dictate against any finding that

the defendant acted outside its authority:

Indeed, where a decision is thoroughly suffused by facts, policies, discretions,

subjective appreciations and expertise, the margin of appreciation may be so wide

that, absent bad faith, it is hard to see how the remedial stage could ever be

reached.⁶¹²

⁶⁰⁹Submissions of the Plaintiff at para. 486

⁶¹⁰Taylor v. Canada (Health), supra (fn. 17) at para. 60

⁶¹¹Taylor v. Canada (Attorney General), supra (fn. 35) at para. 111

⁶¹²Paradis Honey Ltd. v. Canada (Attorney General), supra (fn. 601) at paras. 127 and137

Page: 185

[545] This case does not reach the point where the remedial stage would need to be

considered.⁶¹³

[546] This leaves the Court to consider this case as founded in negligence. This too has been

the subject of some consternation, thought and inquiry. In an article entitled “Before Kamloops:

The Canadian Law of Public Authority Liability That Might Have Been”⁶¹⁴the author posits that

the Canadian treatment of the issue has been sidetracked. He begins by noting that there are two

general approaches to liability in negligence of public authorities:

First, there is the Diceyan approach, under which public authorities can owe a

duty of care only in situations where a similarly situated private person would

owe a duty of care. Second, there is the approach under which unique duties of

care, duties which have no application as between private persons, are imposed on

public authorities.

[547] The author proposes that, to our collective detriment, with the appearance of Anns v.

Merton London Borough Council and its adoption in Kamloops v. (City) v. Nielsen, Canada

began an experiment into imposing broader duties of care in negligence law in general and on

public authorities in particular. We have taken up the second approach. The article suggests that

our allegiance to Anns “…belies inconsistent adherence”:

But despite three decades of inventing, adopting, modifying, or ignoring various

legal concepts and tests for public authority liability, the official orthodoxy

supposes an unbroken continuity of legal doctrine from Anns to the present. The

claim cannot be reconciled to the outcomes in individual cases.

[548] The article wonders about what the author sees as a return to an earlier, if “nascent”,

approach founded on the application of Hedley Byrne v. Heller⁶¹⁵to public authorities. This

requires a broader understanding of the principle in that case than is typically described:

The underlying principle [of Hedley Byrne] rested on an assumption of

responsibility by the defendant towards the plaintiff, coupled with a reliance by

the plaintiff on the exercise by the defendant of due skill and care. The principle

that a duty of care could arise in that way was not limited to a case concerned

with the giving of information or advice (the Hedley Byrne case) but could

include the performance of other services.⁶¹⁶

⁶¹³Well known cases where public officials acted outside their authority (for an improper purpose and referenced in

Paradis Honey at para. 86 are Re Multi-Malls Inc. and Minister of Transportation and Communications (1977),

1976 CanLII 623 (ON CA), 14 O.R. (2d) 49, 73 D.L.R. (3d) 18 (C.A.), where the Minister of Transportation refused

access permits to the adjacent highway for “planning reasons”; Doctors Hospital v. Minister of Health et

al. (1976), 1976 CanLII 739 (ON SC), 12 O.R. (2d) 164, 68 D.L.R. (3d) 220 (Div. Ct.) where it was proposed to

close the hospital for economic reasons which was beyond the authority given in the applicable regulation.

⁶¹⁴de Vries, Jonathan; Supreme Court Law Review (2019) 93 S.C.L.R. (2d) 117

⁶¹⁵(1964) AC 465 (HL)

⁶¹⁶Michael v. Chief Constable of South Wales Police, [2015] A.C. 1732 at para. 67 (U.K. S.C.)

Page: 186

[549] The author of the article describes the result: “Under its broader interpretation the

principle of Hedley Byrne extends to any situation in which a defendant has interfered, whether

by a representation or some other reliance-inducing action, in the autonomous choices of a

plaintiff, resulting in a loss that the plaintiff would not have otherwise suffered.” The article

considers the work of G.H.L. Fridman in assessing the post-Hedley Byrne law of public liability

and concludes that it was (and presumably still could be) possible for negligence law to deal with

issues of government action that caused harm to private citizens within the law of obligations,

and without the need to carve out special duties, tests and immunities for public actors. Needless

to say, no submissions were made on this account. I mention it only to demonstrate the breadth

of the consideration being brought to bear on the issue.

[550] The submissions of both sides consider the case to be decided by the Court from the

perspective of the approach and tests set out by Anns v. Merton London Borough Council.

Application of those tests answers the first of the common issues set in this case: “Did Canada

owe a duty of care to class members?” I alluded to that test earlier in these reasons. The two

stage approach the test represents is summarized in Edwards v. Law Society of Upper Canada:

At the first stage of the Anns test, the question is whether the circumstances

disclose reasonably foreseeable harm and proximity sufficient to establish a prima

facie duty of care. The focus at this stage is on factors arising from the

relationship between the plaintiff and the defendant, including broad

considerations of policy. The starting point for this analysis is to determine

whether there are analogous categories of cases in which proximity has previously

been recognized. If no such cases exist, the question then becomes whether a new

duty of care should be recognized in the circumstances. Mere foreseeability is not

enough to establish a prima facie duty of care. The plaintiff must also show

proximity — that the defendant was in a close and direct relationship to him or

her such that it is just to impose a duty of care in the circumstances. ...

If the plaintiff is successful at the first stage of Anns such that a prima facie duty

of care has been established (despite the fact that the proposed duty does not fall

within an already recognized category of recovery), the second stage of the Anns

test must be addressed. That question is whether there exist residual policy

considerations which justify denying liability. Residual policy considerations

include, among other things, the effect of recognizing that duty of care on other

legal obligations, its impact on the legal system and, in a less precise but

important consideration, the effect of imposing liability on society in general.⁶¹⁷

[551] In Attis v. Canada (Health) the Court of Appeal found that it was reasonably foreseeable

618

that unsafe medical devices could cause harm to consumers.

The Crown does not contest

foreseeability in this case.⁶¹⁹

⁶¹⁷2001 SCC 80, [2001] 3 S.C.R. 562 (S.C.C.), at paras. 9-10 quoted in Taylor v. Canada (Attorney General), supra

(fn. 35) at para. 72.

⁶¹⁸Supra (fn. 22) at para. 52

Page: 187

[552] This takes these reasons to the issue of proximity. The Submissions of the Plaintiff

contend that there are analogous cases in which proximity has previously been recognized.

Particular reliance is placed on Fullowka v. Pinkerton’s of Canada Ltd.⁶²⁰This proposition has

already been dealt with by the Court of Appeal. It considered this question as part of the special

case heard by the five-judge panel in 2012 in respect of the certification of this case:

No prior case is a perfect fit for this one, otherwise there would be no need to redo

the proximity analysis. In Fullowka, the regulator was physically present in the

mine on several occasions and was required by statute to directly regulate the

conduct of the miners. Those features, which do not exist in this case, render the

relationship between the regulator and the miners in Fullowka closer than the

relationship between Health Canada and the recipients of the implants.⁶²¹

[553] The Court went on to consider the possibility of an analogous determination by reference

to a second case, Doe v. Metropolitan Toronto (Municipality) Commissioners of Police:⁶²²

Similarly, in Doe, the police were aware that the plaintiff was one of a handful of

persons who had potentially been targeted by a serial rapist. The police were also

under a specific statutory duty to prevent crime. That degree of specificity is not

present on the facts as alleged in this case.⁶²³

[554] In the Submissions of the Plaintiff, counsel for the Plaintiff and the Ontario Health

Insurance Plan (“OHIP”) also rely on Brewer Bros. v. Canada⁶²⁴as a case dealing with an

analogous situation rendering any specific analysis as to the presence of proximity unnecessary.

It is not and it does not. The case does not deal with proximity. The duty discussed sprung from

the statute. In Brewer the Federal Court of Appeal upheld a decision finding that a duty of care

was owed by the Canadian Grain Commission to grain producers who sold their grain to a grain

elevator operator licensed by the Commission. The Commission was found to owe a duty of care

to take proactive steps to protect the producer from financial losses occasioned by the bankruptcy

of the licensed operator. The Court examined the legislation and determined that:

The statute provides strong evidence of a private law duty of care.⁶²⁵

[555] What is now Health Canada owes its statutory responsibilities to the “public at large”.

This was acknowledged by the Submissions of the Plaintiff.⁶²⁶This is directly opposite to

Brewer Bros., where the duty was found to be owed to a “defined group”:

⁶¹⁹Submissions of the Defendant at para. 272

⁶²⁰[2010] 1 S.C.R. 132, [2010] S.C.J. No. 5, 2010 SCC 5 (CanLII),

⁶²¹Taylor v. Canada (Attorney General), supra (fn. 35) at para. 112

⁶²²74 OR (2d) 225, [1990] OJ No 1584 (QL),72 DLR (4th) 580, 40 OAC 161

⁶²³Taylor v. Canada (Attorney General), supra (fn. 35) at para. 113

⁶²⁴1991 CanLII 8184 (FCA), [1992] 1 FC 25, 80 DLR (4th) 321, 5 FTR 325, [1991] FCJ No 456 (QL)

⁶²⁵Brewer Bros. v. Canada, ibid at para. 56

⁶²⁶Submissions of the Plaintiff at para. 338

Page: 188

…This differs from the case at bar. Parliament has expressly provided for the

protection of interests of members of a defined group — the holders of documents

— and in a particular manner, viz., by requiring the posting of security to the

satisfaction of the Commission and by ensuring the availability of a remedy to the

holders of documents either indirectly or by direct action pursuant to s. 38(2) of

the Act.⁶²⁷

[556] In the absence of an analogous case, the Court of Appeal turned its inquiry to the

question of whether, in the circumstances of this case, the proximity necessary to establish a new

demonstration of a duty of care was present:

If the claim does not fall within an established or an analogous category, but the

harm alleged was reasonably [page182] foreseeable, proximity becomes the focus

of the first stage of the two-stage duty of care inquiry. Where the claim is

advanced against a regulator, the proximity inquiry will focus initially on the

applicable legislative scheme and, secondly, on the interactions, if any, between

the regulator or governmental authority and the putative plaintiff.⁶²⁸

[557] The Court of Appeal confirmed what had been found in both Attis v. Canada and Drady

v. Canada, that the legislative scheme did not impose a private duty of care:

I begin with the statutory regime. As outlined above, Attis and Drady dealt with

the same legislative scheme that is before the court in this proceeding. Both cases

held that the scheme did not expressly or by implication create a private law duty

of care. Nor did the scheme foreclose the existence of that duty in a particular

situation.⁶²⁹

[558] The Court acknowledged there was no reason to re-examine the question of whether the

terms of the legislation demonstrated the presence of a duty of care:

Neither party in this proceeding suggests that the court should reconsider the

analysis of the legislative scheme conducted in Attis and Drady. I see no reason to

rework that ground.

[559] And went on to find that the fulcrum on which the issue turned was the interaction

between the class and the defendant:

⁶²⁷Brewer Bros. v. Canada, supra (fn. 624) at para. 60

⁶²⁸Taylor v. Canada (Attorney General), supra (fn. 35) at para. 75 citing R. v. Imperial Tobacco 2011 SCC 42,

[2011] 2 SCR 45 at paras. 43-45

⁶²⁹Taylor v. Canada (Attorney General), supra (fn. 35) at para. 101

Page: 189

The fate of these pleadings turns on whether they allege a sufficient interaction

between Health Canada and the plaintiff to warrant a finding of proximity and the

imposition of a prima facie duty of care.⁶³⁰

[560] It is at this point that the Court of Appeal rejected the finding in Sauer and concluded that

a public acknowledgment by a regulator of its public duties was insufficient demonstration of the

interaction necessary to be the foundation for a finding that there was a duty of care owed by that

regulator (see para. [28] above).

[561] I turn to the telephone calls made by Trudy Tallon, her husband, Katherine Madden with

her mother, and Judy Munro to Health and Welfare Canada. Are these telephone calls

demonstrative of the direct contact the Court of Appeal said was not alleged in respect of the

representative plaintiff, Kathryn Anne Taylor? (see para. [34] above). They are not. Do they

demonstrate interaction sufficient to indicate the presence of a of duty care? They do not.

[562] At some point in the early 1990’s, after her implant had been removed and after the

recall, Trudy Tallon and her husband, David Bullough, who also gave evidence in this trial,

contacted the United States Food and Drug Administration. They were referred to Health and

Welfare Canada. They were looking for information. Generally, over the course of 1994-2001,

each year, they telephoned Health and Welfare Canada in order to obtain information on Vitek

Proplast implants.⁶³¹These telephone calls represent direct contact between Trudy Tallon and

Health and Welfare Canada. The issue raised is whether such calls, made when they were,

demonstrate the proximity necessary as the basis for a duty of care owed by Health and Welfare

Canada to the class. These telephone calls began four years after the recall.

[563] The telephone calls raise the prospect of the second of the two mentioned options:

proximity supporting a private duty of care raised as a result of specific interaction between the

parties involved.

[564] The telephone calls made by Trudy Tallon and her husband do not represent broad public

statements on which she relied. They are direct interactions specific to her. It is difficult to see

how such communications could be dealt with as a common question applicable to the class as a

whole. Surely, each case would depend on its own facts: was such a call or series of calls made?

What was said and what reliance, if any was placed on it? On its face, calls made by the

individual claiming a duty of care, seeking information would not demonstrate action by the

regulator taking on such a responsibility and, based on the evidence in this case, did not do so

here.

[565] In the case of Katherine Madden, she never received a Vitek Proplast implant. The

purpose of her telephone calls were to provide information, not to realize on, or create a

relationship that was the foundation for a duty of care. Like the telephone communication

involving Trudy Tallon and her husband, these calls, the fax and letter she sent are direct

⁶³⁰Taylor v. Canada (Attorney General), supra (fn. 35) at para. 102

⁶³¹Transcript of Trudy Tallon (April 5, 2019) pp. 21-23 and see Transcript of David Bullough (April 5, 2019) at pp.

39-40

Page: 190

communication between representatives of Health and Welfare Canada and a patient. They are

not the sort of community or public notifications that could reasonably be taken as demonstrating

the proximity necessary to found a private duty of care owed by the regulator to the class. Insofar

as the individual patient, in this case, Katherine Madden, is concerned, they are a further

demonstration of the idea that each case would have to be governed by its own facts, not as part

of a common question within a class proceeding. Katherine Madden never received a Vitek

Proplast Implant of any kind. There can be no private duty of care owed to her in respect of the

treatment of such implants by Health and Welfare Canada as the regulator.

[566] The telephone calls made by Judy Munro were to the Hotline set up for the purpose of

communication between Health and Welfare Canada and those with concerns arising from

having received a Proplast based implant. This was an effort to help individuals and not to take

on a duty of care in connection with the granting of any Notice of Compliance. Judy Munro had

retained a lawyer. These calls put him in communication with Health and Welfare Canada. This

communication does not serve as a demonstration of the proximity on which a duty of care could

be based. It was after the fact, that is, after the implantation and after the harm and difficulties

had became apparent.

[567] I return to the limitations that have descended from the history of this action. The Court

of Appeal in considering the certification of this proceeding left open the possibility that

misrepresentations by the Crown as to its knowledge of the risk of harm to the class, seen as a

definable and relatively small group of consumers, could be a demonstration of proximity

between the Crown and the class. As it has transpired, the evidence does not demonstrate the

presence of the misrepresentations referred to by the Court of Appeal as leaving open the

possibility of a valid claim. From a broad perspective, it is clear that the understanding of the

potential for harm was not present as suggested by Robert Pilliar and Pierre Blais. It evolved

over time. There was no “knowledge” that could have been, or was, the source of

misrepresentations by the Crown. No device dedicated solely for use as a temporomandibular

joint implant was ever issued a Notice of Compliance. Only “Block and Sheeting” received this

form of authorization. The determination of whether the product should be used in any particular

case rests with the health professionals involved. From a more limited perspective, the only

specific allegation of misrepresentation rests with Information Letter 765, which says there were

four types of Vitek Proplast temporomandibular implants that were issued Notices of

Compliance when they had not been. As has already been said, this letter was sent to

manufacturers and distributors. There is no evidence that any surgeon or other professional ever

saw or read this letter and no evidence that it was relied on in furtherance of deciding to use one

of the devices improperly referred to as having received a Notice of Compliance.

[568] Insofar as proximity is concerned only a narrow option remains available. The

Submissions of the Plaintiff rely on the presence of a small, definable group which stood in

proximity to the Crown and to which, it is said, a duty of care is owed. What is a definable

group? Identifying the group only by the alleged wrong is not enough. If the group is understood

to be anybody who received a Vitek Proplast temporomandibular joint implant, absent some

other defining characteristic, it could be anybody. In this case, at the time the acts of the Crown

alleged to have been negligent took place, no one could know who, if anyone, would

subsequently receive one of the offending implants. The names of Canadian citizens and

Page: 191

residents who were in pain and candidates to receive a temporomandibular joint implant would

have been unknown and impossible to identify.

[569] In Hill v. Hamilton-Wentworth Police Services⁶³², the plaintiff was investigated by the

police, arrested, tried, wrongfully convicted and ultimately acquitted but only after spending 20

months in jail. He commenced an action against the police including a claim for negligence. At

trial the action was dismissed. The Court of Appeal recognized the tort of negligent investigation

but the majority found that the police were not negligent in the way the investigation had been

carried out. The plaintiff appealed the finding that the police had not been negligent and the

police cross-appealed from the determination that there is a tort of negligent investigation. In the

Supreme Court of Canada, the majority held that the police are not immune from liability under

the law of negligence and that the tort of negligent investigation exists in Canada. Police officers

owe a duty of care to suspects. However, this was not a circumstance where the identity of the

plaintiff was unknown and discovered only after, or as part of, the impugned investigation. To

the contrary, he was the subject of the investigation. Because he had been identified as the

subject of the investigation it was foreseeable that he, specifically, could suffer at the hands of an

improper and negligent investigation. He was, in the words of the case “targeted”:⁶³³

The analysis in Hill, in relation to whether there was sufficient proximity between

the police investigators and a particularized suspect, is instructive. The most basic

factor relevant to proximity is whether there is a relationship between the alleged

wrongdoer and the victim, usually described as “close and direct” (para. 29). The

focus is on whether the actions of the alleged wrongdoer have a close and direct

effect on the victim.⁶³⁴

[570] There is no suggestion that, from 1975 to 1988, anyone or any group known to Health

and Welfare Canada were identified as candidates for receipt of a temporomandibular joint

implant. There cannot be a relationship, much less a close one, where one side is not known and

cannot be identified

[571] In Doe v. Metropolitan Toronto (Municipality) Commissioners of Police it was alleged

that the police were aware of the existence of a serial rapist. It was “eminently foreseeable” that

he would strike again.⁶³⁵The plaintiff alleged that by the time she was raped, the police knew or

ought to have known that she had become part of a narrow and distinct group of potential

victims, sufficient to support a special relationship of proximity. According to the allegations the

police knew:

(1) that the rapist confined his attacks to a particular and limited area of Toronto;

(2) that the victims all resided in second or third floor apartments;

⁶³²2007 SCC 41 (CanLII), [2007] 3 SCR 129, 87 OR (3d) 397, 368 NR 1, [2007] CarswellOnt 6265, [2007] SCJ No

41 (QL), 285 DLR (4th) 620, 230 OAC 253

⁶³³Hill v. Hamilton - Wentworth Police Services, ibid at paras. 34, 118, 132, 139, 140, 146 and 154

⁶³⁴Fullowka v. Pinkerton's of Canada Ltd., supra (fn. 620) at para. 40

⁶³⁵Doe v. Metropolitan Toronto (Municipality) Commissioners of Police, supra (fn. 622) at p. 230

Page: 192

(3) that entry in each case was gained through a balcony door; and

(4) that the victims were all white, single and female.

[572] This was sufficient to support a finding that a private law duty of care could be

established. The harm was foreseeable and a special relationship of proximity existed.⁶³⁶

Accordingly, as with Hill and unlike the case before this Court, more was known as the allegedly

negligent actions were taking place that allowed the police to identify a relatively small group, a

group removed from the general public, that made the risk to that group foreseeable and

demonstrated a relationship of proximity.

[573] There is more that serves to distinguish that case from this one. In that case, quite apart

from the identified group, there was the allegations of an immediate relationship between the

plaintiff and the police akin to that which existed in Hill v. Hamilton-Wentworth Police Services.

The plaintiff alleged that the police made a conscious decision to sacrifice her in order to

apprehend the suspect. They decided to use her as “bait”. They chose not to warn her due to a

stereotypical belief that because she was a woman, she and others like her would become

hysterical. This would have “scared off” the attacker, making his capture more difficult. ⁶³⁷

[574] The Plaintiff referred to Fullowka v. Pinkerton’s of Canada Ltd. There was a strike in a

mine. It became particularly contentious and violent. There was a riot which damaged property

and injured security guards and replacement workers. Over the next weeks the situation grew

somewhat calmer but problems did persist. There were two explosions, one which damaged a

satellite dish and another the mine’s ventilation system. Thereafter, a miner went underground

and planted an explosive device. Nine miners were killed in the explosion. The miners’ survivors

sued, among others, the mine owner, the security company and the territorial government for

negligently failing to prevent the murders. The Supreme Court of Canada upheld the decision of

the Court of Appeal finding a duty of care owed by the government and the security company to

the miners. There were factors which showed that the relationship between the plaintiff and both

the security company and the territorial government were sufficiently close and direct to give rise

to a duty of care. In the case of the government, the relationship was between the inspectors and

the miners. The mine inspectors had a statutory duty to inspect the mine and to order the

cessation of work if they considered it unsafe. In exercising this statutory power, the inspectors

had been physically present in the mine on many occasions, had identified specific and serious

risks to an identified group of workers, and knew that the steps being taken by management and

the security company to maintain safe working conditions were wholly ineffectual.

[575] The difference between Fullowka and this case is the same as with Hill and Doe. In the

time before the explosion if the government inspectors had considered the problem, they would

have been able to identify those people at risk: the miners. Here in the period leading up to the

issuance and refusal of Notices of Compliance, if those acting in the name of the Health

Protection Branch had considered the issue, they would not have been able to identify the group

⁶³⁶Ibid at p. 231

⁶³⁷Ibid at p. 231

Page: 193

at risk. No one could have known who would be likely to receive any one of the implants at

issue.

[576] Put differently, this is not a case like Fullowka where the group of persons to whom a

duty of care was found to be owed was small and clearly defined. As acknowledged by the

Plaintiff, when enforcing the Medical Devices Regulations or in evaluating submissions for a

Notice of Compliance, Health Canada was exercising “responsibilities to the public at large” not

to a small, discrete and identifiable group. From the regulator’s perspective, anyone in Canada

had the potential to become a recipient of a Vitek Proplast-Teflon IPI.

[577] This difficulty is a manifestation of the limitation that arose through the long history of

this litigation associated with the failure to provide any definition to the size and membership of

the class. As early as the first certification decision in 2007 the Court indicated concern for the

suggested size of the class at 2,600. That number was offered because it was 10% of the number

of these devices distributed in the United States. The population of Canada is 10% of that of the

United States. The Court of Appeal anticipated that the group would be small. The number

produced through the inspection undertaken as part of the recall was 162. Even at the first

inspection all Proplast devices were held at Instrumentarium Inc. There is no substantive

evidence that any of these devices were “privately imported” and, if there were some, nothing to

suggest the numbers would run anywhere nearly as high as 2,600. And yet, in the Submissions of

the Plaintiff there is a continued reliance on a prospective class of “approximately 2,500 – 2,600

Canadians”.⁶³⁸No one has any substantive idea of who they were, how many there are, if there

are any at all. How can there be a small group of identified consumers? There cannot. The

necessary “close and direct relationship” cannot be present.

[578] Not only was there no misrepresentation as alleged before, and as relied on by the Court

of Appeal, there was no identified group that could be foreseen as at risk. Thus, there can be no

proximity and no duty of care.

[579] The Plaintiff sees this differently. On her behalf it is asserted that:

…all members of the class were known or capable of being known by Health

Canada at the time a duty of care arose.

[580] No statement was made as to when that was. Rather the paragraph goes on:

Ms. Jacques testified as to the existence of Vitek customer records at

Instrumentarium that enabled her and her colleagues to identify the number and

location of 162 Vitek Proplast TMJ interpositional implant recipients.

[581] Francine Jacques (Gaudette) did not testify that Health and Welfare Canada could

identify the number and location of the recipients of the Vitek Proplast-Teflon IPI’s that had

been sold by Instrumentarium Inc. As part of her role in monitoring Instrumentarium Inc.’s recall

of the Proplast devices, Francine Jacques (Gaudette) was provided with a letter sent to sales

⁶³⁸Submissions of the Plaintiff at para. 3

Page: 194

representatives that set out information regarding its sales to hospitals and surgeons but not to

individual patients. Neither Instrumentarium Inc. nor Health and Welfare Canada ever had that

information. The identification of the 162 units was part of the investigation taken as part of the

recall. This was well after any time proximity and a duty of care might have arisen. The origin of

the alleged breach of the duty of care is said to be the negligent issuance of Notices of

Compliance, most of which, in fact, were not granted. There were four said to have been granted

as attested to in Information Letter 765. Whereas the Plaintiff’s position had been that these

devices, in fact, were not granted Notices of Compliance and that the negligence was in

misleading people as to that fact, in the Submissions of the Plaintiff it is said the Notices of

Compliance were granted but negligently. The Notices of Compliance granted were for Block

and Sheeting” and these devices were for a broader set of purposes and not for use as

temporomandibular implants. There is no substantive evidence that anyone did use these devices

for that purpose.

[582] The paragraph in the Submissions of the Plaintiff goes on:

Instrumentarium’s files would have reasonably disclosed all other Vitek implant

customers and their locations across Canada.

[583] It is not clear there were any other Vitek Proplast customers. Francine Jacques (Gaudette)

did instruct Instrumentarium Inc. to hold back all Proplast products, not just the interpositional

implants.

[584] The paragraph in the Submissions of the Plaintiff concludes:

Health Canada was also in possession of a defined Vitek consignee list

comprising [200]⁶³⁹surgeons at least one of whom had engaged in the private

importation of Vitek Proplast TMJ implants.⁶⁴⁰

[585] The list of Canadian surgeons was identified, not as a list of consignees, but as a list of

doctors who had expressed an interest in the product. In any case, the tripartite meeting which

involved Canadian, American and British regulators and which introduced the fact that a list of

Canadian surgeons existed took place on May 28, 1991. It was not made available to Health and

Welfare Canada until June 18, 1991. This was after the recall. The one surgeon being referred to

is the Manitoba oral surgeon the Submissions of the Plaintiff say secured implants “through

private importation”.⁶⁴¹I repeat what has already been said, the memorandum of Robert Scales

reports that the surgeon purchased implants from Instrumentarium Inc. (see para. [438] above).

[586] The Submissions of the Plaintiff also suggest that proximity is established through

contact between the Instrumentarium Inc. and the inspectors:

⁶³⁹The number that appears in the Submissions of the Plaintiff is 207. I believe this to be a typographical error. The

consignee list was said, in evidence, to be of 200 surgeons. 207 is the total number of Vitek Proplast IPI TMJ

implants accounted for by Francine Jacques (Gaudette) when she visited Instrumentarium Inc. as part of the recall.

⁶⁴⁰Submissions of the Plaintiff at para. 281

⁶⁴¹Ibid at para. 440

Page: 195

…In this case Ms. Jacques testified, Health Canada had prior contact with

Instrumentarium going back seven years prior to the inspection to 1979 and as

recently as December 1985 when Instrumentarium sought information on the

importation of a Part V device under the same regulatory controls as Vitek

Proplast TMJ implants. Furthermore, both Ms. Jacques and Mr. Scales testified to

the regular review of customs manifests related to the importation of medical

devices. The customs surveillance program, formally instituted in 1983, would

have resulted in multiple points of contact between Instrumentarium and Health

Canada

[587] The first sentence of this paragraph states:

With regards to direct and personal dealings, the Supreme Court looked at the

extent of prior inspections and contact between the inspectors…⁶⁴²

[588] This is a reference to Fullowka. The circumstances there were substantially different than

they are here. In that case, the Supreme Court of Canada observed:

In exercising this statutory power, the inspectors had been physically present in

the mine on many occasions, had identified specific and serious risks to an

identified group of workers and knew that the steps being taken by management

and Pinkerton’s to maintain safe working conditions were wholly ineffectual.

[589] In the case before the Court there were not “frequent visits” to Instrumentarium Inc.

There had been two inspections. The purpose was not to identify specific or serious risks. To the

contrary, these visits were part of a program directed to working in a cooperative manner to

instruct and advise, in this case Instrumentarium Inc., as to the requirements necessary to bring

product to market and to attempt to bring about voluntary compliance with the amended

regulations. No serious risks had been identified or were apparent. This only came later.

Moreover, this does not deal with a relationship between the inspector (the Crown) and the

victim with whom proximity is required to found the presence of a duty of care:

The focus is on whether the actions of the alleged wrongdoer have a close and

direct effect on the victim. … In Hill, the Chief Justice emphasized that the

relationship between the police and a particularized suspect was closer than that

between the regulator and the public which had been in

issue in Edwards and Cooper. In those cases, the public officials were acting in

relation to a third party, that is, the person being regulated who, in turn, interacted

with the claimant (para. 33). In contrast, in Hill the police interacted directly with

the suspect who was the claimant.⁶⁴³

[590] As noted in the Submissions of the Defendant, the issuance of Notices of Compliance

does not have a direct effect on members of the purported class because whether, what, when and

⁶⁴²Ibid at para. 282

⁶⁴³Fullowka v. Pinkerton's of Canada Ltd., supra (fn. 620) at para. 40

Page: 196

how to implant is always the decision of an intermediary, a doctor, in consultation with a patient.

There is nothing in the issuance of a Notice of Compliance that creates a distinct of more direct

connection to the plaintiff than to the public at large.

[591] For the most part, the submissions made as demonstrating proximity are not that. They

reflect on actions and relationships that took place after the concerns, problems and difficulties

with Vitek Proplast temporomandibular implants were established and accepted. These events do

not found proximity and a duty of care. They are allegations that a supposed duty of care, already

established, was breached. As in the Submissions of the Defendant:

At its highest, the plaintiff’s claim amounts to a series of allegations that Health

Canada breached the [Food and Drugs Act] by not taking the enforcement actions

to prevent Vitek’s TMJ devices from being sold in Canada before 1988, and

breached the [Medical Devices Regulations] by issuing [Notices of Compliance]

for Proplast facial block and sheeting (and apparently also for TMJ devices) in

1988. …⁶⁴⁴

[592] It is possible that a duty of care could arise later, say at the time of the recall. This would

require the taking on of a legal responsibility, through a proximity established at that later time,

in this case once the problems had been identified. Presumably, an assumption of such a

responsibility taken at that time would suggest, when things go wrong, the possibility of liability

for actions and activities that occurred thereafter. To put it more clearly, any responsibility for

negligence would not be in respect of any harm associated with the implanting of these devices

but only for whatever extension to the harm took place after the duty of care was assumed and as

a result of actions taken at that later time. I expect, it would apply to any delay in treatment

caused as a result of demonstrated negligence that occurred after taking on of a duty of care. As

it is, no submissions were made on behalf of the Plaintiff that establish the existence of a duty of

care with respect to the activities surrounding the recall as opposed to the breach of a supposed

duty of care associated with the granting and refusal to grant Notices of Compliance.

[593] This takes these reasons back to the distinction between this case and Hill, Doe and

Fullowka. Proximity, and therefore a duty of care, cannot arise from the activities that are the

foundation of the claim (the investigation, the rape, the explosion and in this situation the recall

and associated activities). It arises from a relationship already in place.⁶⁴⁵In this case, the

plaintiff has failed to establish proximity between Health and Welfare Canada and members of

the supposed class. Without proximity, there is no duty of care. Without a duty of care there can

be no liability for negligence.

[594] This being so there is no need for me to proceed further. Nonetheless recognizing the

time this has taken, the need for these issues to be resolved and recognizing the prospect that,

regardless of the outcome, this matter may be the subject of an appeal, I go further.

Foreseeability not being questioned, if there was proximity, a prima facie duty of care would be

⁶⁴⁴Submission of the Defendant at para. 297

⁶⁴⁵In Hill the plaintiff was targeted. In Doe the plaintiff lived in a targeted part of the city in an apartment with an

accessible balcony and in Fullowka the miners had interaction with the mine inspectors.

Page: 197

established. This would take these reasons to the second stage of the test from Anns v. Merton

London Borough Council. It is for the Defendant, the Crown, to establish the presence of

ancillary policy reasons that dictate that the duty should be limited or set aside. This inquiry

reflects “on the broad societal and legal implications of imposing a duty of care”.⁶⁴⁶As such it

extends beyond considerations bound up in the particular relationship:

… government immunity for policy decisions is not based on the parties'

relationship, but "is better viewed as an immunity imposed because of

considerations outside the relationship for policy reasons -- more precisely,

because it is inappropriate for courts to second-guess elected legislators on policy

matters"… ⁶⁴⁷

[595] Given the history of this proceeding, I take the time to point out that the decision of the

Court of Appeal in 2012 never got to this issue:

The questions posed in this special case focus exclusively on the first stage of the

duty of care inquiry...⁶⁴⁸

[596] An examination of the question should begin with a consideration of the sources

available to establish the policy which informs the actions being scrutinized. In our lexicon

“policy” is an amorphous word. It lacks focus. It is not uncommon for Ministers of the Crown to

make announcements as to the “policy” of the government. Rarely, is it known what

consideration has gone into or who has been involved in developing the expressed ideas. A

speech from the throne, which opens a new parliamentary or legislative session is a more formal

recitation of the policy of the government of the day. The Planning Act⁶⁴⁹contains a provision

allowing for the publication of “policy statements”.⁶⁵⁰The Planning Act requires that decisions

made or advice given by the responsible agencies and government actors be consistent with those

policy statements.⁶⁵¹The principal source to understand the applicable policy for consideration

⁶⁴⁶Attis v. Canada (Health),supra (fn. 22) at para. 73 referring to Cooper v. Hobart, supra (fn. 599) at para. 37 and

Holland v. Saskatchewan, [2008] S.C.J. No. 43, 2008 SCC 42 (CanLII), EYB 2008-136658, J.E. 2008-1434, 167

A.C.W.S. (3d) 427 at para. 10 and see Drady v. Canada (Health), supra (fn. 3) at para. 24, Hill v. Hamilton -

Wentworth Police Services supra (fn. 632) at para. 46

⁶⁴⁷Attis v. Canada (Health), supra (fn. 22) at para. 32 quoting Cooper v. Hobart, [2001] 3 S.C.R. 537, [2001] S.C.J.

No. 76, 2001 SCC 79 (CanLII), 206 D.L.R. (4th) 193 at para. 38

⁶⁴⁸Taylor v. Canada (Attorney General), supra (fn. 35) at para. 73

⁶⁴⁹R.S.O. 1990, c P. 13

⁶⁵⁰Planning Act s. 3 (1) states:

The Minister, or the Minister together with any other minister of the Crown, may from time to

time issue policy statements that have been approved by the Lieutenant Governor in Council on

matters relating to municipal planning that in the opinion of the Minister are of provincial

interest.

[Emphasis added]

⁶⁵¹Planning s. 3(5) and (6) say, in part:

Page: 198

of stage two of the test in Anns v. Merton London Borough Council is the statutes and regulations

that inform the issues at hand. In this case that would be the Food and Drugs Act and the

Medical Devices Regulations. These are legislative emanations of the governments and stand as

substantive demonstrations of its intention in respect of medical devices. I begin with this. The

mandate of the Minister and therefore the Ministry is not, and was not, to a particular group or

segment of our society but to all of us.

[597] The responsibility of the Minister of Health is to the people of Canada:

The powers, duties and functions of the Minister extend to and include all matters

over which Parliament has jurisdiction relating to the promotion and preservation

of the health of the people of Canada not by law assigned to any other department,

board or agency of the Government of Canada. ⁶⁵²

[598] The intended direction of this responsibility was explained in Attis v. Canada:

… the umbrella statute of the Department of Health Act, at s. 4, provides that the

Minister’s obligations are to the people of Canada for the promotion of their

health and the prevention of risk generally. Thus, under this statute, the Minister’s

duty is to the people of Canada as a whole, not to individual residents.⁶⁵³

[599] Even at this overarching phase, the policy directive in the legislation is contrary to any

understanding that a duty of care is to be owed by the Crown to any individual or presumably

any group of individuals. The responsibility is an umbrella covering us all through responsible

regulation as opposed to an assumption of direct or immediate liability.

[600] The regulation of food, drugs, cosmetics and medical devices in Canada is carried out

under the legislative authority of the Food and Drugs Act. It was first enacted in 1920. In 1953

Parliament added a provision dealing with medical devices.⁶⁵⁴At that time, the Minister of

(5) A decision of the council of a municipality, a local board, a planning board, a minister of the

Crown and a ministry, board, commission or agency of the government, including the Tribunal,

in respect of the exercise of any authority that affects a planning matter,

(a) shall be consistent with the policy statements issued under subsection (1) that are in

effect on the date of the decision;….

(6) Comments, submissions or advice affecting a planning matter that are provided by the

council of a municipality, a local board, a planning board, a minister or ministry, board,

commission or agency of the government,

(a) shall be consistent with the policy statements issued under subsection (1) that are in

effect on the date the comments, submissions or advice are provided;…

⁶⁵²Department of Health Act S.C 1996, c. 8 at s. 4(1)

⁶⁵³Attis v. Canada (Health), supra (fn. 22) at para. 54

⁶⁵⁴SC 1953, c. 38

Page: 199

National Health and Welfare emphasized that the Food and Drugs Act created duties to the

public, as a whole, and that the legislation depended heavily on the co-operation of industry:

The purpose of the bill of course is to protect the Canadian people in matters of

health as well as fraud in the manufacturing and sale of food and drugs. The

administration of the measure depends upon the co-operation that the officials of

the department are able to enjoy with industry… The bill is concerned with the

prohibition of things that are injurious to health and that are unfit for use, and with

the prevention of deception in the manufacture and sale of goods consumed by the

public.⁶⁵⁵

[Emphasis added]

[601] Prior to the promulgation of the first Medical Devices Regulations, in 1975, medical

devices were regulated solely by the provisions of the Food and Drugs Act. Through a series of

prohibitions, the legislation placed the obligation for the safety of medical devices on the

manufacturers and distributors, not on the Crown:

No person shall sell any device that, when used according to directions or under

such conditions as are customary or usual, may cause injury to the health of the

purchaser or user thereof.⁶⁵⁶

[602] It is the person “selling” on whom the obligation is placed:

Importantly, s. 19 of the FDA, deals directly with the safety of medical devices,

explicitly places the obligation for the safety of the devices on the manufacturer

and distributor when it says “no person shall sell” any unsafe device. As the

motion judge concluded, no obligations are placed on the government.⁶⁵⁷

[603] The same can be said for s. 20 of the Food and Drugs Act. It imposes a further

prohibition. This one on packaging:

No person shall label, package, treat, process, sell or advertise any device in a

manner that is false, misleading or deceptive or is likely to create an erroneous

impression regarding its design, construction, performance, intended use,

quantity, character, value, composition, merit or safety.⁶⁵⁸

[604] Part II of the Food and Drugs Act, as it was, and as it is, sets out the Crown’s powers of

administration and enforcement. Under this part, any person designated as a Food and Drug

Inspector had and has powers of entry and inspection for the purposes of enforcing compliance

⁶⁵⁵House of Commons Debates, April 21, 1953 at p. 4141

⁶⁵⁶1952-53, c. 38, at s. 19.

⁶⁵⁷Attis v. Canada (Health), supra (fn. 22) at para. 56

⁶⁵⁸Food and Drugs Act 1970 c. F. 27 and 1985 F. 27 both at s. 20

Page: 200

with the Food and Drugs Act and the accompanying regulations.⁶⁵⁹As the Court of Appeal has

held, these powers of enforcement are entirely discretionary. They are not mandatory:

While the FDA and its regulations provided mechanisms for Health Canada to

enforce compliance, enforcement was entirely discretionary. It was not

mandatory. Moreover, the legislative scheme envisaged no relationship between

Health Canada and the consumer of the medical devices. …⁶⁶⁰

[605] This demonstrates that the role of the Crown is within the legislative scheme and the

policy that informs it. It is not one of legal responsibility, that is the role of those who bring the

product to the market. The role of the Crown is to see that bringing these products to market is

done in a fashion that meets the policy directive of the legislative scheme.

[606] The Medical Devices Regulations were introduced on September 2, 1975.⁶⁶¹At the outset

the Crown was not required to play an active role in the entry of new devices into the market in

Canada. At that time, the regulations prohibited the sale of a medical device in Canada unless

tests had been conducted indicating that the benefits claimed to be obtainable through the use of

the device were justified and that such evidence was available in Canada. Manufacturers were

only required to provide Health and Welfare Canada with evidence establishing the safety of a

device when requested to do so by Health and Welfare Canada.⁶⁶²

[607] Part II of the 1975 Medical Devices Regulations (Device Notification and Material)

established new requirements for notifying Health and Welfare Canada of medical device sales.

Under this part, a manufacturer of a device (or a person authorized to act on its behalf) was

required to provide Health and Welfare Canada with a notification of sale before April 1, 1976,

or within ten days of the date of first sale in Canada, whichever was later.⁶⁶³The 1975 Medical

Devices Regulations did not require Health and Welfare Canada to conduct any review of the

safety or efficacy of a device prior to its entry into the Canadian market. The general

understanding was that the work in respect of bringing medical devices to market was to be

undertaken by the industry (the manufacturer and the distributor).

[608] Pre-market review for “new devices” was added to the Medical Devices Regulations on

March 25, 1977.⁶⁶⁴Under the 1977 Medical Devices Regulations, a manufacturer of a “new

device” was prohibited from selling the device or advertising it for sale in Canada unless the

manufacturer first received a Notice of Compliance from Health and Welfare Canada.⁶⁶⁵To

obtain a Notice of Compliance, the Medical Devices Regulations required the manufacturer to

submit to Health and Welfare Canada evidence of the safety and efficacy of the device.⁶⁶⁶Where

⁶⁵⁹Ibid at ss. 22-32 and 1985 F. 27 at ss. 22-37

⁶⁶⁰Drady v. Canada, supra (fn. 3) at para. 38

⁶⁶¹Medical Devices Regulations SOR/75-526

⁶⁶²Ibid at ss. 13 and 27 as well as Agreed Statement of Facts at para. 16

⁶⁶³Ibid at s. 23

⁶⁶⁴Medical Devices Regulations SOR/77-258 Sch. II, s. 28

⁶⁶⁵Ibid at ss. 29 and 30

⁶⁶⁶Ibid at Sch. II, s. 31

Page: 201

Health and Welfare Canada was not satisfied that the manufacturer had provided substantial

evidence of the required criteria, it was to refuse to issue a Notice of Compliance and to inform

the manufacturer of the reasons for the refusal.⁶⁶⁷

[609] The responsibility to provide the information that informed pre-market review was the

manufacturers.

[610] In deciding that a Notice of Compliance was to be issued, the Director, who made that

determination, was not making a decision by which the Crown took on any of the legal

responsibility associated with the eventual safety or efficacy of the device:

The Regulations were clear that the Director "shall" issue the notice of

compliance if he or she is satisfied that the manufacturer has provided "substantial

evidence" to support the criteria set out in s. 36(a). The Director did not make a

determination as to the ultimate efficacy of the device, the risks associated with

the use of the device, or the adequacy of any warnings or instructions provided

with the device.⁶⁶⁸

[611] Health and Welfare Canada did not conduct its review for substantial evidence of safety

to humans in a vacuum. Under section 36(a)(ii) of the Medical Devices Regulations, Health and

Welfare Canada’s review for substantial evidence of safety and efficacy was guided by the

intended purpose and use of the device specified by the manufacturer under section 35(1)(a)(ii).

(see para [77] above). All of the materials and information were to be submitted by the

manufacturer.⁶⁶⁹The issue for Health and Welfare Canada’s consideration was whether the

manufacturer had submitted substantial evidence that the new device could be used “for the

purpose and under the conditions of use recommended by the manufacturer without undue risk to

humans”⁶⁷⁰[Emphasis added]. The Medical Devices Regulations did not require, and Health and

Welfare Canada did not conduct, independent safety and efficacy testing as part of the process of

reviewing submissions for a Notice of Compliance:

The regulations in force during the time frame defined by the appellants simply

particularized and provided mechanisms to enforce compliance with the

legislation's objective. A reading of the legislative history of the regulations

discloses that there was no obligation on Health Canada to undertake safety and

efficacy testing, or to engage any other compliance or enforcement mechanism.⁶⁷¹

⁶⁶⁷Medical Devices Regulations 1978 c. 871, s. 36(b)

⁶⁶⁸Taylor v. Canada (Attorney General), supra (fn. 35) at para. 59

⁶⁶⁹The Medical Devices Regulations s. 35(1) begins:

For the purposes of obtaining a notice of compliance the manufacturer of a new device shall

submit to the Director… (quoted at para. [77] above)

⁶⁷⁰Medical Devices Regulations s. 36(a)(ii) (quoted at para. [78] above)

⁶⁷¹Attis v. Canada (Health), supra (fn. 22) at para. 57

Page: 202

[612] In February 1981, Health and Welfare Canada made a submission to the Cabinet

Committee on Social Development for additional funding for the medical devices program.⁶⁷²

The need for additional funding was due, in part, to the proliferation of medical devices coming

into the Canadian market.⁶⁷³With the request for additional resources, Health and Welfare

Canada also asked Cabinet to define Canada’s policy with respect to the regulation of medical

devices.⁶⁷⁴There were three different regulatory approaches that ministers were asked to

consider: the conventional approach; self-regulation; and the collaborative approach.⁶⁷⁵The

choice provided was reviewed in the evidence provided by Janice Hopkins. The collaborative

approach was selected. Under this approach Health and Welfare Canada would depend primarily

on collaboration with industry and professional users (i.e. doctors, dentists, surgeons, hospitals,

etc.). The goal was to ensure the safety and efficacy of medical devices, while prioritizing

governmental regulation for devices that presented the highest degree of risk to individual

users.⁶⁷⁶In practical terms, a collaborative regulatory approach would permit the Department to

ensure “reasonable probability of safety and effectiveness of the highest priority inventions for

open marketing” and the ability to take corrective and preventative actions in response to reports

of the most severe device failures:⁶⁷⁷

The regulations simply authorized Health Canada to enforce the various aspects

of the compliance requirements if it chose to do so. Thus, Health Canada was akin

to an overseer or watchdog, able to employ discretionary, but not mandatory,

enforcement of the legislative scheme.⁶⁷⁸

[613] Emblematic of this co-operative, collaborative approach, in which the Crown is more

watchdog than police officer, is the understanding that the issuance of a Notice of Compliance

did not signify Health and Welfare Canada’s approval of the device:

A Notice of Compliance issued by the [Health Protection] Branch after evaluation

of the submission does not signify approval. It does, however, provide users with

assurance that the Branch is satisfied that the manufacturer has carried out tests

and has submitted appropriate results to demonstrate a reasonable probability of

safety and effectiveness in humans. The onus of ensuring safety and effectiveness

of the device remains with the manufacturer.⁶⁷⁹

[614] In 1984, Health and Welfare Canada published a Guide to the Preparation of a

Submission Pursuant to Part V of the Medical Devices Regulations. It was provided to

⁶⁷²Exhibit 55, T.1 and T. 2 (The Cabinet Committee on Social Development was comprised of a selection of 10

ministers, including the Minister of National Health and Welfare (Transcript of Janice Hopkins (June 10, 2019) at p.

21; Exhibit 55, T. 3)

⁶⁷³Transcript of Janice Hopkins (June 10, 2019) at p. 45

⁶⁷⁴Ibid at p. 46-47

⁶⁷⁵Exhibit 55, T. 2 pp. 9-11

⁶⁷⁶Transcript of Janice Hopkins (June 10, 2019) at pp. 49-50

⁶⁷⁷Exhibit 55, T. 2 p. 23

⁶⁷⁸Attis v. Canada (Health), supra (fn. 22) at para. 57

⁶⁷⁹Exhibit 19 (Information Letter No. 638 – January 12, 1983) at p. 2

Page: 203

manufacturers and distributors. It made clear their responsibility and the limits on the role of the

Crown:

It must be noted that there is no authority or mechanism under the Food and

Drugs Act to approve a medical device prior to its sale in Canada. It is the

responsibility of the manufacturer to ensure that the regulatory requirements are

met.⁶⁸⁰

[615] The limits of what could be taken from the issuance of a Notice of Compliance was

explained by Pierre Blais:

With respect to medical devices such as dental implants, Canada’s Health

Protection Branch does not “approve the use of these products. It issues a

document called a Notice of Compliance”; this confirms that the manufacturer has

complied with basic and usually very modest disclosure requirements for the

manufacturing technology in the clinical history of the product.

It does not mean that the clinical safety is assured, that the manufacturing process

is scientifically valid, that the embodied technology is the best available or that

the quality assurance protocol is most appropriate. Furthermore, there is no

mandate to verify or duplicate the scientific and clinical data submitted or

independently test the products to confirm that they are consistently manufactured

using the stated methods or produced to the claimed levels of quality assurance.⁶⁸¹

[616] This approach is the manifestation of the direction, found in the Medical Devices

Regulation, to strive in each case to find the appropriate balance between “efficacy” on the one

hand, and “safety” on the other.⁶⁸²It was understood that, in the search for benefits, there are

risks and that some would, in the normal course, be realized:

It was understood that a lot of the problems started to occur with products by the

time they reached in the fifth or the fourth year and that’s when, you know, all the

difficulties started to come and all the failures or whatever was happening would

start to get noted. In a lot of, in a lot of cases, you know, it was believed, you

know, in five years, we will start knowing exactly where this stands.⁶⁸³

[617] The point of this policy was not to set the Crown with a duty of care. Rather it was to

allow for reasonable parameters within which to find the balance between benefit and risk which

was engaged when any device was brought to market. The evidence, at trial, produced examples

of what can be anticipated. Heather Sheardown explained that, in the United States, cornea

implants were allowed into the market. There was a failure rate of 50%. Some recipients went

⁶⁸⁰Exhibit 48 (Guide to the Preparation of a Submission Pursuant to Part V of the Medical Devices Regulations) at

p. 3

⁶⁸¹Exhibit 34, T. 56; Transcript of Pierre Blais (May 8, 2019) at p. 177

⁶⁸²Medical Devices Regulations 1978 c. 871, s. 36 (quoted at para. [78] above)

⁶⁸³Transcript of Nirmala Chopra (April 23, 2019) at pp. 26-27

Page: 204

blind. In Canada, surgeons were eager to utilize Cotrel rods to assist their patients. They had to

wait until the required material was provided and a Notice of Compliance issued. In the perfect

world, the former never would have happened; the latter would have been permitted into the

market more quickly. In the case of Cotrel rods, it can be said that the delay was made shorter, in

part, through the collaboration between the manufacturer and those responsible for receiving and

reviewing the submissions that led to the issuance of Notices of Compliance.

[618] If I am wrong in what I have found; if the analysis required by the first stage in the test

put in place by Anns v. Merton London Borough Council demonstrates there is a prima facie

duty of care owed by the Crown to the members of the class, I would find that there are residual

policy reasons which justify denying liability. The policy, which the legislation and regulation

supports, is directed to all Canadians and to our collective benefit bringing to those in need

medical devices that will bring relief. The balance between efficacy and safety which is at the

foundation of this policy accepts that, for some, there are risks that may be realized. However, to

fasten the Crown with a duty of care to those individuals would upset the policy. The balance

would be skewed by the need of the Crown to minimize its liability by refusing to allow new

devices into the market until it had assurance of the long-term benefit and absence of risk. In

such circumstances there might well be fewer cornea implants but there would also be more, I

suggest many more, devices like Cotrel rods where benefit would be unnecessarily delayed.

[619] This is still not the end of what is required to bring this case to an end. The Supreme

Court of Canada has distinguished the policy concerns of stage two of the test in Anns from what

is referred to as “operational” concerns:

It is at this second stage of the analysis that the distinction between government

policy and execution of policy falls to be considered. It is established that

government actors are not liable in negligence for policy decisions, but only

operational decisions. The basis of this immunity is that policy is the prerogative

of the elected Legislature. It is inappropriate for courts to impose liability for the

consequences of a particular policy decision. On the other hand, a government

actor may be liable in negligence for the manner in which it executes or carries

out the policy. In our view, the exclusion of liability for policy decisions is

properly regarded as an application of the second stage of the Anns test. The

exclusion does not relate to the relationship between the parties. Apart from the

legal characterization of the government duty as a matter of policy, plaintiffs can

and do recover. The exclusion of liability is better viewed as an immunity

imposed because of considerations outside the relationship for policy reasons –

more precisely, because it is inappropriate for courts to second-guess elected

legislators on policy matters. …⁶⁸⁴

[620] Are there operational concerns with what has taken place in respect of Vitek Proplast

temporomandibular joint implants which would suggest a breach of a duty of care if any had

been found to exist, and to be maintained even in the face of the particular policy considerations

⁶⁸⁴Cooper v. Hobart, supra (fn. 599) at para. 38

Page: 205

to be applied? In such circumstance what would be the applicable standard of care? The standard

of care rests on the idea of reasonableness. What would a reasonable person with the requisite

knowledge, experience and responsibilities do in the situation being evaluated? In Hill v.

Hamilton-Wentworth Regional Police Services Board the proposition was simply stated:

…the standard of care is based on what a reasonable police officer would do in

similar circumstances.⁶⁸⁵

[621] The same point is more broadly said in Ryan v. Victoria (City) as follows:

Conduct is negligent if it creates an objectively unreasonable risk of harm. To

avoid liability, a person must exercise the standard of care that would be expected

of an ordinary, reasonable and prudent person in the same circumstances. The

measure of what is reasonable depends on the facts of each case, including the

likelihood of a known or foreseeable harm, the gravity of that harm, and the

burden or cost which would be incurred to prevent the injury. In addition, one

may look to external indicators of reasonable conduct, such as custom, industry

practice, and statutory or regulatory standards.⁶⁸⁶

[622] Generally speaking, a reasonable regulator’s job is to administer its authorizing statute.

Those powers should be exercised in light of relevant information and for the purpose of

advancing the statute’s objectives. Reasonable regulators evaluate relevant information and

choose a regulatory response in good faith based on their assessment of what best promotes the

statutory purpose in the circumstances. The mere existence of a power to control a risky situation

does not mean that the reasonable regulator must deploy that power in all cases to eliminate risk,

particularly when judged with the benefit of hindsight.⁶⁸⁷

[623] The fundamental allegation of negligence is that those acting on behalf of the Crown

knew or should have recognized the dangers of Proplast and were negligent in allowing

temporomandibular joints that included Proplast to be used in Canada, and that the failure

extended to the time when they did act in response to those dangers. Those actions also breached

the standard relying on what the reasonable regulator would or should have done in that

situation. It will be clear to anyone reviewing these reasons, particularly the section entitled:

“What Was Known About Proplast, by Whom and When Was It Known” that I would be

unprepared to find that the standard of care as it is applies to this situation was breached.

[624] The actions and statements of those involved at the material time do not serve to support

the allegation that the Crown fell short of the standard. Pierre Blais suggested in his evidence

that he sought the prohibition on the use of Proplast as far back as 1977 when he attended the

Gordon Conference at which, as he described it, pandemonium broke out in opposition to the

⁶⁸⁵Hill v. Hamilton-Wentworth Police Services, supra (fn. 632) at para. 44.

⁶⁸⁶1999 CanLII 706 (SCC), [1999] 1 SCR 201, 168 DLR (4th) 513, [1999] 6 WWR 61, [1999] SCJ No 7 (QL), 59

BCLR (3d) 81, 117 BCAC 103 at para. 28

⁶⁸⁷This paragraph is a quotation from the Submissions of the Defendant (at para. 347) which I adopt as an

appropriate explanation of reasonableness as it should be applied in this case.

Page: 206

presentation made by Charles Homsy, identified during the trial as the individual who developed

Proplast. Pierre Blais told the Court that when he returned to Canada, he proposed a prohibition

on the use of Proplast in Canada, that this recommendation was supported by his immediate

superiors but was rejected by more senior officials when the idea was taken to them. There is

nothing which supports this, no document or any other evidence. Pierre Blais went on to suggest

that his concern resulted in a continuous set of discussions which went on over the 14 years of

his employment with the Health Protection Branch and that it involved the “mere totality of the

early generation of evaluators” and later “other members of the department”. He said there was

“unanimity in the belief that the product was very damaging”. When taken as a whole none of

this is supported by the evidence.

[625] The only document that refers to the Gordon Conference is the one from May 18, 1981

entitled “A Need for Enhanced Regulatory Control of Invasive Medical Devices.” It does not

recommend prohibition. It suggests that these products should be placed in a special category

and made subject to close supervision. In the end this document and its reuse the following year

contributed to the inclusion of implants that were to be left in the body for 30 days on the

Schedule attached to Part V of the Medical Devices Regulation, meaning they were to be treated

as “new devices” the use of which required recognition through the granting of a Notice of

Compliance. This was akin to what Pierre Blais was shown to have requested in the document. It

was accepted by Pierre Blais as appropriate given what was known at the time.

[626] Pierre Blais took part in the preparation of a book: “Biomaterials in Reconstructive

Surgery.” The book included a chapter about Proplast. The chapter recognizes concerns. More

study was required. Pierre Blais was one of the editors of the book. Collectively they included

the chapter because it recognized the possibility that Proplast might still fulfill at least some of its

promise. Pierre Blais did not indicate that he had any objection to this inclusion; to the contrary

he agreed with the decision. Interestingly, this decision was made in 1979, four years before

publication and three years after the Gordon Conference.

[627] There is nothing that confirms there was any commonly held view, within the Health

Protection Branch, that Proplast was dangerous or that Pierre Blais had so informed his

colleagues. Nancy Shadeed was aware of Pierre Blais but reported that he never discussed his

research or laboratory work with her. He never reviewed any concerns he had about materials

used in the manufacture of medical devices. She had no independent awareness of his

research.⁶⁸⁸Similarly Richard Lawuyi did not discuss the Vitek implants, or for that matter

anything else of substance with Pierre Blais.⁶⁸⁹Louis Boulay was aware of Pierre Blais but

suggested that with the 1983 amendment to the Schedule to Part V of the Medical Devices

Regulations Pierre Blais “was more involved on the research side than the review side.” It would

have been unusual for Pierre Blais to have been involved in pre-market review. Pierre Blais

never approached Louis Boulay about Proplast.⁶⁹⁰In her evidence, Lindsay Blaney made no

particular reference to any communication with Pierre Blais in respect of Proplast or any other

⁶⁸⁸Transcript of Nancy Shadeed (May 23, 2019) at p.67

⁶⁸⁹Transcript of Richard Lawuyi (May 28, 2019) at pp. 55, 76 (On one occasion they discussed Pierre Blais’

research on silicone breast implants.)

⁶⁹⁰Transcript of Louis Boulay (June 11, 2019) at p. 20, 21 and 22

Page: 207

issue. Francine Jacques (Gaudette) did discuss Cotrel rods with Pierre Blais and had at least one

other conversation with him but nothing of great consequence. ⁶⁹¹Janice Hopkins was aware of

Pierre Blais but never had an occasion to discuss Proplast with him.⁶⁹²One person who did speak

with Pierre Blais was Nirmala Chopra. She testified that the evaluators consulted him often

regarding different types of material. She said that the 1981 to 1982 period was when they began

to hear about Proplast. They were not sure “what it was doing… we needed to study it more.”⁶⁹³

It is evident that Nirmala Chopra did review Proplast and other materials with Pierre Blais. Her

understanding was that the evaluators also spoke with him. This, it would seem, is not accurate.

She directed Nancy Shadeed to speak to Pierre Blais ⁶⁹⁴but, from the evidence of Nancy

Shadeed, she did not. By the time Richard Lawuyi conducted his review, Nirmala Chopra was no

longer with the Medical Devices Bureau.

[628] What do I take from this? It may be that the Crown believes that the evidence of Pierre

Blais should be disregarded. I do not understand why it was thought necessary to prepare, what

on its face seems to be, the approval of the paper: “Frangible, Degradable and Dispersible

Implant Materials” by copying what was a proper approval of another paper. However, I am not

prepared to allow that fact to jettison all that was offered by Pierre Blais. As I have said, he was,

for a significant period of time, considered to be a valued employee. On the other hand, the

Plaintiff believes that Pierre Blais is the light which guides the circumstances as she sees them.

That is to say that the danger presented by Proplast was clear from the beginning, that the

officials of the Crown knew this, or should have recognized it and the failure to act was

demonstrative of their collective negligence. I do not accept this either. It is more than forty

years since Pierre Blais went to work for the Medical Devices Bureau and that long since he

attended the Gordon Conference, which is where the evidence as to his personal experience with

Proplast began. Memory is uncertain. It can mislead us as to the substance and nature of our

involvement in events long passed. In the absence of any specific confirmation I do not accept

that Pierre Blais pushed for the prohibition of Proplast. To the contrary, he accepted the changes

to the Medical Devices Regulations as typical of the evolution of this sort of regulatory tool and

the outcome of the request for change, being the addition of implants that would remain in the

body for 30 days as subject to Part V of the Medical Devices Regulations, as providing a level of

protection for the public. It was a form of “enhanced regulatory control”: a new classification

criterion for devices subject to Part V requirements (see para. [130] above). At the material time,

as opposed to when he appeared at the trial, Pierre Blais agreed that the chapter of the Rubin text,

that dealt with Proplast, should remain in that publication because it was possible that Charles

Homsy was right, that Proplast could be useful and of assistance to patients. I find that Pierre

Blais was not central, as he believes himself to have been, to whatever debate took place inside

the Health Protection Branch. For the most part, those who testified, and were directly involved,

never discussed Proplast with him. It may be that Nirmala Chopra and Pierre Blais talked about

Proplast but there is little that suggests these conversations went further. It should not be

forgotten that she left after Nancy Shadeed found the submissions made with respect to Propast

⁶⁹¹Transcript of Francine Jacques (June 17, 2019) at p. 82-83, 95

⁶⁹²Transcript of Janice Hopkins (June 10, 2019) at p. 105

⁶⁹³Transcript of Nirmala Chopra (April 11, 2019) at p. 25-26 and (April 23, 2019) at p. 28

⁶⁹⁴Transcript of Nirmala Chopra (April 24, 2019) at pp.76 and 100

Page: 208

insufficient, but before Richard Lawuyi recommended that Proplast Block and Sheeting be

issued Notices of Compliance.

[629] In short I do not accept that anything that Pierre Blais said should be taken as showing

negligence by or on behalf of the Crown. There was no consensus against the use of Proplast.

The early signs were positive as demonstrated by the work of Wolford and Gallagher, Kiersch,

Brown, Moriconi as well as Block, Kent and Homsy, all reported on in evidence from Doran

Ryan. This was joined by the retrieval analysis conduced by the University of Minnesota School

of dentistry in the early 2000’s and presented at the 68^thAnnual Meeting and Scientific Sessions

of the American Association of Oral and Maxillofacial Surgeons. It was confirmed by the

literature review undertaken by Christopher Ober. Heather Sheardown reported on a study

published in 2008.

[630] Each of Doran Ryan, Daniel Tomlak and Eliot Wayne Tunis implanted Proplast devices,

generally in the period between 1983 and 1987, Doran Ryan in the United States, the other two

in Canada. They all stopped, but not because of any general consensus or understanding. In his

March 1989 letter to the editor of the Journal of Oral and Maxillofacial Surgery, Doran Ryan

acknowledged the good faith of those involved in promoting the product and that there were

others who saw these implants as having had “great success”. He referred to three papers (1987,

1990 and 1992) which were favourable in their views. He invited Charles Homsy to attend a

conference to discuss problems with the product. Doran Ryan continued to investigate to come to

a better understanding of the product. In the years leading to his arrival in Thunder Bay, Daniel

Tomlak worked with top oral maxillofacial surgeons in the United States. They supported the use

of Proplast devices. He introduced these devices to his colleagues in Thunder Bay. As a result of

an informal discussion in Vancouver he stopped. This does not support the idea of a general

consensus. Some people made favourable comments. There was no discussion of bone

deterioration or fragmentation of the material. The substance of the expressed concern was that

more of the Proplast devices than had been expected had been taken out (explanted). The study

referred to by Elliot Wayne Tunis was limited and the conclusion mixed, some patients did well

while others did not.

[631] There was no certain understanding of Proplast that would have driven any reasonable

person responsible for its regulation to conclude it was dangerous. Over the period of time

referred to, the understanding of the impact of Proplast developed and evolved through its use,

experience and analysis. As it is, the first evaluator, Nancy Shadeed, did not accept the

submissions seeking Notices of Compliance as being complete. She rejected them. The second

evaluator, Richard Lawuyi, rejected those that were specifically dedicated to use as

temporomandibular implants but recommended those that were more general (but directed to

non-orthopaedic uses) for the issuance of such notices. The actual use was left to the medical

professionals to judge.

[632] It is concerning that Richard Lawuyi said he did not read the product monograph. It is

not, as he suggested, just promotional material. He should have read the one prepared in respect

of “Block and Sheeting (the one dealing with the products that received Notices of Compliance).

In the end there is no suggestion that his failure to do so had any practical impact. There is no

demonstrated example of any individual who was implanted with Block and Sheeting in the time

Page: 209

period after the Notices of Compliance were issued. In any case “Indications” and

“Contraindications” are nothing more than suggestions from a “positive” and “negative”

perspective. On the one hand, the prospective use is advisable, on the other hand, it would be ill-

advised. The ultimate decision is for the surgeon with the particular issue, confronted by the

particular patient, in mind. The idea, raised in the Reply Submissions of the Plaintiff as to “the

depth and degree of the review [conducted by Richard Lawuyi] of the 20 binders” that make up

the 1988 submission, misses the point. For the most part, the applications for Notices of

Compliance were refused. Where this is so, the Plaintiff can have no complaint. As to what form

of product monograph that was actually sent out with any Block and Sheeting that was sold, I

point out, again, there is no evidence that any doctor or surgeon read and was misled by the

product monograph. Such a reading would not likely be credible given the import of

“Indications” and “Contraindication” in these Monographs and the ultimate responsibility borne

by the medical professionals to determine whether a particular use of these products would be or

could be helpful to a patient. Even so, I repeat, there is no substantive evidence that any one was

implanted with Block and Sheeting in the temporomandibular joint (or, for that matter, anywhere

else). In these circumstances the proposition that Richard Lawuyi says now, 35 years after these

implants were put in place, that the product monograph for Block and Sheeting should have been

clarified does not change the overall impact of questions raised by this document.

[633] I return to the question of whether Francine Jacques (Gaudette) was misled into negligent

conduct by her mistaken belief that certain of the Vitek Proplast temporomandibular joints were

subject to Notices of Compliance when they were not and her supposed subsequent failure to

stop their importation. I note this is a hypothetical question because there is no evidence that any

of these particular devices were on any import list produced and reviewed by Francine Jacques

(Gaudette) or, for that matter, that anyone was implanted with them. I also point out that, as

matters stand, following the completion and delivery of the Submissions of the Plaintiff, it is

difficult for the Plaintiff to rely on this theoretical error because, as those submissions reveal, it is

the Plaintiff’s position that these devices were in fact approved. This being so there would be no

basis to stop them from being imported. I have made clear I do not accept this proposition. The

fact remains that there is no obligation under the Medical Devices Regulation to stop all products

without Notices of Compliance at the border. To say otherwise would suggest that any duty of

care imposed on the Health Protection Branch would extend to what happens at the border or,

conversely covers the border authorities such that they would be negligent for not stopping every

device lacking a Notice of Compliance. A reading of the Customs Surveillance Program makes

clear that the border review is not designed to be a wall that blocks importation. It is a tool to be

used as part of a co-operative program to bring to market medical devices which had a prospect

of assisting patients. Insofar as refusing entry is concerned the program was to improve the

capability to stop product at the border, not to close off the importation of products. If I were

required to do so I would not find that the actions of Francine Jacques (Gaudette) contribute to

negligence by the Crown.

[634] This leaves the question of whether, assuming a duty of care to be present, the Crown

breached that duty in its handling of the recall. There is nothing in the actions of those acting in

the name of the Crown that suggests a breach of any supposed duty of care. The inspections

carried out before and after the recall were responsibly prepared for, undertaken, reviewed and

followed up on. The published notices and warnings were considered and, in the circumstances,

Page: 210

comprehensive. The decision not to notify every doctor, surgeon and patient was considered and

reasonable.

[635] I answer the common issues, as follows:

1. Canada did not owe a duty of care to class members.

2. Assuming Canada did owe a duty of care to class members, the applicable standard of

care was not breached.

3. Through the evidence produced through doctors, patients, researchers and regulators it

has been demonstrated that Vitek Proplast temporomandibular joint implants can cause

injury to those receiving them. The actual injury caused, in any particular case, would

require individual inquiry.

[636] It follows that the action is dismissed.

COSTS

[637] Rule 12.05 (1) (c) of the Rules of Civil Procedure makes it a requirement that a judgment

in a class proceeding account for the distribution of costs:

A judgment in a class proceeding…shall contain directions with respect to,

…

(c)

the payment of costs of the proceeding.

[638] No submissions have been made as to costs of the trial. If the parties are unable to agree,

as to costs, I may be spoken to.

[639] In the absence of submissions, it is not possible for the Court to understand the position

of the parties as to costs or to make any determination as to what, if any, award should be made.

Nonetheless, it would be unusual not to have some introductory perspective. I think it fair to

make these known to the parties, in the hope they may be helpful. This proceeding has taken

much too long. As Master McGraw noted, and I have repeated, there is little, to my mind no

purpose, in undertaking a review and assessment of responsibility for this. The record suggests

such an examination would point amply in both directions.

[640] There are wider implications to this delay than just the cost. There are people who have

been waiting out the results of this proceeding for in excess of 20 years (for each of them the

implants have been in place for a span of about 35 years). On a psychological level I expect, for

them, this decision will be, at least, disappointing; on a practical level it is impossible to know

the effect. There is a broad public interest in how the administration of justice is perceived and

how it, in fact, impacts on those who are touched by it. I say this cognizant of section 31(1) of

the Class Proceedings Act:

Page: 211

In exercising its discretion with respect to costs under subsection 131 (1) of

the Courts of Justice Act, the court may consider whether the class proceeding

was a test case, raised a novel point of law or involved a matter of public interest;

but also, the comments of the judge who dealt with the original certification motion, heard in

2007. He found the considerations raised by section 31(1) not to be pertinent to this case:

Counsel for the plaintiff submitted – and defendant’s counsel disputed – that, in

the circumstances of this case, the court’s discretion with respect to cost should be

influenced by the provisions of section 31 of the CPA. The section authorises the

court, in the exercise of its discretion, to consider whether the proceeding “was a

test case, raised a novel point of law or involved a matter of public interest”. In

my judgement, none of these considerations is relevant in this case. Class actions

with respect to medical implants have been relatively numerous in Canada. Some

have involved specifically-identified TMJ implants for which substantially similar

claims to those in this action have been made. The possibility that the ultimate

decision in this case – like that in any class proceeding – may be influential in the

final disposition, or a settlement, of the other cases is not, in my opinion,

sufficient to make a “test case”. Although all the cases turn on their own facts, the

points of law in the specific implant cases – as distinct from a case like Drady v.

The Attorney General of Canada [2007] O.J. No. 2812 in which generic industry-

wide claims were made – are sufficiently similar to foreclose a finding of novelty

for the purposes of section 31. Nor do I believe this case falls within the range of

those that are to be considered to have public interest because they have “some

specific special significance for, or interest to, the community at large is on the

members of the proposed class”: Pearson v. Inco Ltd. (2006), 267 D.L.R. (4^th)

111, at para. 9.⁶⁹⁵

[641] For the purpose of these observations, I say only that the judge cannot have foreseen that

it would take a further 12 years to resolve these issues. There was a time when the Crown was

not permitted to seek costs. To the extent that in-house counsel were relied on, they were paid

anyway. There was no additional cost to the Crown in carrying out the proceeding. There was

also a general recognition that the Crown represents us all. In the normal course costs would

follow the event. However, in all the circumstances of this case, and in recognition of the values

considered at that earlier time, I wonder whether this is a case where no costs should be awarded;

each party would bear its own.

Lederer J.

⁶⁹⁵Taylor v. Canada (Endorsement as to Costs, January 15, 2008) (Trial Record at T. 31, para. 10)

Page: 212

Released: February 27, 2020

CITATION: Taylor v. Canada (Attorney General), 2020 ONSC 1192

COURT FILE NO.: CV-181819

DATE: 20200227

ONTARIO

SUPERIOR COURT OF JUSTICE

BETWEEN:

KATHRYN ANNE TAYLOR

Plaintiff

– and –

THE ATTORNEY GENERAL OF CANADA

Defendant

DEFENDANT REASONS FOR JUDGMENT

Lederer, J.

Released: February 27, 2020